Digestive & Liver Diseases Clinical Trials

Condition:

Nonalcoholic steatohepatitis (NASH)

Participant Requirements:

• 18-75 years old (females must not be pregnant or lactating)
• Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or Type 2 diabetes
• Must meet all components of screening lab panel
• Biopsy-proven nonalcoholic steatohepatitis (NASH)

Summary:

The purpose of this study is to evaluate the effectiveness and safety of an experimental drug called efruxifermin (EFX) in patients with nonalcoholic steatohepatitis (NASH). EFX is made by modifying a naturally occurring hormone in the body that affects the balance of metabolism.

Condition:

Nonalcoholic steatohepatitis (NASH), cirrhosis

Key Inclusion Criteria:

• 18-75 years old
• Evidence of portal hypertension
• History confirming NASH cirrhosis
  

Summary:

This study focuses on individuals who may have nonalcoholic steatohepatitis (NASH) cirrhosis (scarring of the liver due to fatty liver disease and inflammation) and have not yet developed any complications of cirrhosis. The purpose of the study is to determine the safety and efficacy of an investigational drug called belapectin (GR-MD-02) for the prevention of esophageal varices (enlarged veins in the esophagus) in NASH cirrhosis.

Condition:

Nonalcoholic Steatohepatitis

Participant Requirements:

• 18-75 years old
• Confirmation of steatohepatitis on a diagnostic liver biopsy
• Fibrosis Stage 1 or greater and below Stage 4 (according to the NASH Clinical Research Network fibrosis staging system)
• Body mass index ≤45 kg/m²

Summary:

This study focuses on patients diagnosed with nonalcoholic steatohepatitis (NASH) with fibrosis (recently confirmed by a liver biopsy) or those who are at high risk of having this disease and are willing to undergo a liver biopsy to determine whether they have NASH with fibrosis. The purpose of the study is to evaluate the safety and effectiveness of an investigational drug called elafibranor in these patients. Researchers will assess the efficacy of elafibranor compared to placebo (inactive substance) for the treatment of NASH. The study will also evaluate whether elafibranor reduces the number of patients that will develop further complications from NASH, such as liver cirrhosis.

Condition: 

Nonalcoholic fatty liver disease (NAFLD), liver disease

Participant Requirements:

• Patients suspected of nonalcoholic fatty liver disease (NAFLD)
  • At least 18 years old
  • Patients scheduled for liver biopsy due to suspicion of NASH are eligible
  • Blood must be drawn within 60 days of liver biopsy

Summary:

This study focuses on individuals who have may have nonalcoholic fatty liver disease (NAFLD). The purpose of the study is to evaluate blood samples and tissue to discover and develop laboratory tests that can detect liver disease, as well as predict and monitor response to treatment.

Condition:

Nonalcoholic steatohepatitis

Participant Requirements:

• 18-75 years old
• Confirmation of nonalcoholic steatohepatitis (NASH) on a diagnostic liver biopsy
• Total NAFLD Activity Score of four or more with at least one in each component of the NAS score

Summary:

This study focuses on individuals diagnosed with nonalcoholic steatohepatitis (NASH) who are overweight or obese and who have prediabetes or Type 2 diabetes. NASH is a chronic liver disease that may cause scarring of the liver and liver failure. The purpose of the study is to evaluate the safety and effectiveness of an investigational drug called aramchol on NASH and NASH-related complications compared to placebo (inactive substance).

Condition: 

Nonalcoholic steatohepatitis (NASH), fibrosis

Participant Requirements:

• At least 18 years old
• Suspected or confirmed diagnosis of nonalcoholic steatohepatitis (NASH) fibrosis
• Not pregnant or breastfeeding

Summary:

The purpose of this study is to evaluate the effects of an investigational drug called MGL-3196 on individuals with nonalcoholic steatohepatitis (NASH). Researchers aim to determine the safety, effectiveness and optimal dosage of MGL-3196, as well as whether treatment with MGL-3196 for several years will benefit participants.

Condition: 

Nonalcoholic steatohepatitis, fibrosis

Participant Requirements:

• Between 18-75 years old (or the minimum country-specific age of consent if >18)
• BMI ≥25 kg/m² (in Africa, Europe, North/South America) or ≥22.5 kg/m² (in Asia)
• Ultrasound-guided liver biopsy meeting the NASH Clinical Research Network definition 

Summary:

This study focuses on individuals who may have an abnormally high amount of fat and swelling (inflammation) of the liver along with some fibrosis (scarring) that is not related to excessive alcohol consumption. The purpose of the study is to determine whether the investigational drugs PF-06865571 and PF-05221304 (PF-06865571 alone or when given together with PF-05221304) improve nonalcoholic steatohepatitis (NASH) with liver fibrosis compared to placebo (inactive substance).

Condition:

Nonalcoholic steatohepatitis

Participant Requirements:

• 18-75 years old
• Nonalcoholic steatohepatitis (NASH) by clinical diagnosis or biopsy
• Overweight or obese with a BMI ≥25 kg/m²

Summary:

This study focuses on individuals who have characteristics associated with nonalcoholic steatohepatitis (NASH). The purpose of the study is to evaluate the safety and tolerability of a drug called TERN-201, given orally (by mouth) in patients who are thought to have NASH, a form of non-alcoholic fatty liver disease (NAFLD).

Condition:

Nonalcoholic steatohepatitis

Participant Requirements:

• Confirmed diagnosis of nonalcoholic steatohepatitis
• 18-75 years old
• Screening MRI-PDFF with ≥8% liver fat fraction

Summary:

The purpose of this study is to determine the safety and effectiveness of an investigational thyroid hormone receptor drug called VK2809 for the treatment of nonalcoholic steatohepatitis (NASH). VK2809 is designed to reduce cholesterol and lower liver fat content.

Condition:

Hepatocellular carcinoma

Participant Requirements:

• At least 18 years old
• Diagnosis of liver cirrhosis
• Diagnosis of hepatocellular carcinoma

Summary:

This study focuses on individuals who have been diagnosed with an early-stage hepatocellular carcinoma (HCC) and who have been treated with therapies targeting the liver. The purpose of the study is to examine the effects that an investigational drug called pravastatin has on the time it takes for HCC to occur again in patients with early-stage HCC. Researchers believe that pravastatin, in combination with therapies targeting the liver, may delay or protect against HCC occurring again.

Pravastatin is a type of statin that is approved by the U.S. Food and Drug Administration (FDA) for various conditions. However, it is not approved by the FDA to delay or protect against HCC occurring again. The study will compare the effects of pravastatin against the effects of a placebo (inactive substance). Participants will be randomly assigned to receive either pravastatin or a placebo.

Condition:

Liver cirrhosis

Summary:

This study focuses on patients with liver cirrhosis (scarring of the liver which results in abnormal liver function). The purpose of the study is to compare the safety and effects of simvastatin in individuals with liver cirrhosis who are at an increased risk for liver cancer. Participants will receive either simvastatin or placebo (inactive substance). Simvastatin is approved by the U.S. Food and Drug Administration for various conditions, but its use in this study is investigational. Previous studies show that simvastatin lowers the risk of heart disease not only by decreasing cholesterol, but also by decreasing inflammation. Researchers believe that this anti-inflammatory effect of simvastatin may delay disease progression to cancer in patients with liver cirrhosis.

Condition:

Colonic inertia

Participant Requirements:

• Patients with colonic inertia
• At least 18 years old

Summary:

The purpose of this pilot study is to identify the causes of a condition called colonic inertia, which involves severe constipation. Often, colonic inertia can only be treated by surgery to remove almost the entire colon (large bowel). Researchers aim to determine whether colonic inertia can be caused by changes in the types of microbes (bugs) that are present in the colon, or possibly by a toxin (poison) produced by particular microbes. Understanding the causes of colonic inertia is the first step in developing future treatments. Participants will be asked to provide stool samples when they are able to, as well as complete a questionnaire.

Condition:

Irritable bowel syndrome

Participant Requirements (IBS participants):

• Must meet Rome II criteria
  • At least 12 weeks of abdominal discomfort or pain that has two of three features:
    • Relieved with defecation and/or
    • Onset associated with a change in frequency of stool and/or
    • Onset associated with a change in form (appearance) of stool

Summary:

The purpose of this study is to understand the causes of irritable bowel syndrome (IBS) by looking at both genetic and immunologic mechanisms. Examination of DNA will enable researchers to understand which gene(s) contributes to the development of IBS. In this study, researchers aim to create a bank of blood for future genetic analyses to identify specific genes responsible for IBS development. They also aim to identify possible tests, such as looking for antibodies (which act as an immune defense) to food poisoning toxins, to help diagnose and evaluate the likelihood that they lead to IBS.

Condition:

Small intestinal bacterial overgrowth, diarrhea

Participant Requirements:

• At least 18 years old

Summary:

The purpose of this study is to find ways to decrease levels of a gas called hydrogen sulfide.  Hydrogen sulfide gas is made by microbes (bugs) in the gut and is linked to small intestinal bacterial overgrowth (SIBO). SIBO is a condition in which there is an excess amount of microbes within the gut (specifically, the small intestine), which can lead to symptoms such as abdominal pain and diarrhea. Researchers aim to test various ways of decreasing levels of the microbes that produce hydrogen sulfide gas, and therefore provide relief from SIBO symptoms.

Condition:

Gastrointestinal symptoms

Participant Requirements:

• At least 18 years old
• New patient visit with a dietician at Cedars-Sinai or University of Michigan
• Access to modern device supporting iOS (tablets, iPads, iPhones, and Android) and internet access

Summary:

This study focuses on patients who are scheduled to see a dietician at a future appointment as part of routine clinical care. The purpose of the study is to evaluate the impact of the My Nutritional Health Application. This mobile app allows individuals to maintain a food diary and track gastrointestinal (GI) symptoms through the Food and Symptoms Tracker (FAST). Researchers aim to examine the relationship between participants’ GI symptoms and food. Once participants have downloaded the app, they will be prompted to answer questions related to food intake and mental or physical symptoms that may suggest food intolerance. A member of the study team will reach out to participants to assist with any technical difficulties or to answer questions.

Condition

Gastrointestinal disorders

Participant Requirements

• 18-85 years old
• Undergoing oral double balloon endoscopy or esophagogastroduodenoscopy
• Must not have had any colon prep

Summary

This study focuses on patients who are undergoing either an oral double balloon endoscopy procedure or an esophagogastroduodenoscopy procedure as part of their clinical care. The purpose of the study is to understand how microorganisms in the gut affect individuals and how they may contribute to gut-related human diseases.

Condition:

Irritable bowel syndrome

Participant Requirements:

• 18-75 years old
• Meets Rome IV criteria for IBS-D or IBS-M
• Participants should report urgency with bowel movement at least once a week

Summary:

This study focuses on individuals who have had chronic diarrhea for at least the past three months and who are at least 18 years old. The purpose of the study is to examine how well the antibiotic rifaximin (xifaxan) works in patients who have visceral hypersensitivity caused by irritable bowel syndrome with diarrhea (IBS-D) or mixed irritable bowel syndrome (IBS-M).  Visceral hypersensitivity is the term used to describe internal pain (mainly abdominal pain and rectal pain) in patients with IBS. Researchers aim to determine whether rifaximin helps decrease visceral hypersensitivity and whether decreases in visceral hypersensitivity are associated with decreases in small intestinal bacterial overgrowth (SIBO). SIBO is a common condition in patients with IBS.  

Condition:

Liver cancer

Participant Requirements:

Patients who are about to begin treatment for advanced liver cancer at Cedars-Sinai.

Summary:

The purpose of the study is to determine how bacteria in the digestive tract could contribute to  response to liver cancer treatment. The bacteria in the digestive tract help maintain a healthy immune system and may therefore affect how the body responds to treatments that target the immune system. Researchers will evaluate data in participants' medical records; oral and stool samples will be collected to characterize bacteria in the digestive tract.

Condition:

Liver cirrhosis, hepatocellular carcinoma

Participant Requirements:

• At least 18 years old
• Diagnosed with liver cirrhosis
• Requires an upper gastrointestinal endoscopy by a Cedars-Sinai, UCLA and Veterans Affairs Greater Los Angeles Healthcare System gastroenterologist for standard of care

Summary:

This study focuses on patients who have liver cirrhosis. There is growing evidence that individuals with cirrhosis have changes in their gastrointestinal systems, including changes to the types of microbes that make up their gastrointestinal tract. Changes to these microbes may lead to inflammation (swelling) and other issues related to a worsening of liver disease. In this study, researchers aim to measure and evaluate changes in the intestines and throughout the entire body of patients with liver cirrhosis by collecting tissue and fluid samples from the small intestine (duodenum), as well as blood samples. In order to investigate the lifestyle factors that might be associated with these changes, participants will also be asked to complete questionnaires about dietary intake, lifestyle habits, medications and medical history. Patients will be followed over time to study changes in their disease.

Condition:

Primary biliary cirrhosis

Participant Requirements:

• Definite or probable PBC diagnosis
• At least 18 years old
• A mean total bilirubin greater than upper limit of normal (ULN) and ≤3 X ULN or an alkaline phosphatase >5 X ULN

Summary:

This study focuses on patients who have primary biliary cholangitis (PBC), a progressive liver disease caused by a buildup of bile that results in damage to the bile ducts that drain bile from the liver. The purpose of the study is to evaluate the investigational use of a drug called obeticholic acid (also known as OCA) and its effect on PBC when given with ursodeoxycholic acid. OCA is a man-made version of a natural compound produced in the liver called bile acid. Researchers aim to determine the safety and effectiveness of OCA in delaying specific medical conditions or health-related issues that can occur in patients with PBC.

The current standard of care for adults with PBC is ursodeoxycholic acid for an indefinite length of time. In this study, researchers will compare OCA to the standard treatment to learn which is more effective.

Condition:

Ascites, liver cirrhosis

Participant Requirements:

• At least 18 years old
• Cirrhosis of the liver 
• Refractory or recurrent ascites primarily managed with periodic therapeutic paracentesis (a procedure in which fluid in the abdomen is removed by inserting a needle and drawing out the fluid)

Summary:

This study focuses on individuals who have been diagnosed with refractory or recurrent ascites due to liver cirrhosis (a condition in which scarring of the liver causes a buildup of fluid in the abdomen). The purpose of the study is to determine whether an investigational device called the Alfapump System can effectively move excess peritoneal fluid from a patient’s abdomen into the bladder, where it can be eliminated through normal urination.

Condition:

Hepatocellular carcinoma

Participant Requirements:

• At least 18 years old
• Diagnosis of liver cirrhosis
• Diagnosis of hepatocellular carcinoma

Summary:

This study focuses on individuals who have been diagnosed with an early-stage hepatocellular carcinoma (HCC) and who have been treated with therapies targeting the liver. The purpose of the study is to examine the effects that an investigational drug called pravastatin has on the time it takes for HCC to occur again in patients with early-stage HCC. Researchers believe that pravastatin, in combination with therapies targeting the liver, may delay or protect against HCC occurring again.

Pravastatin is a type of statin that is approved by the U.S. Food and Drug Administration (FDA) for various conditions. However, it is not approved by the FDA to delay or protect against HCC occurring again. The study will compare the effects of pravastatin against the effects of a placebo (inactive substance). Participants will be randomly assigned to receive either pravastatin or a placebo.

Condition:

Liver cirrhosis

Summary:

This study focuses on patients with liver cirrhosis (scarring of the liver which results in abnormal liver function). The purpose of the study is to compare the safety and effects of simvastatin in individuals with liver cirrhosis who are at an increased risk for liver cancer. Participants will receive either simvastatin or placebo (inactive substance). Simvastatin is approved by the U.S. Food and Drug Administration for various conditions, but its use in this study is investigational. Previous studies show that simvastatin lowers the risk of heart disease not only by decreasing cholesterol, but also by decreasing inflammation. Researchers believe that this anti-inflammatory effect of simvastatin may delay disease progression to cancer in patients with liver cirrhosis.

Condition:

Primary sclerosing cholangitis

Participant Requirements (Core Study):

• At least 18 years old
• Confirmed diagnosis of primary sclerosing cholangitis (PSC)

Summary:

The purpose of this study is to evaluate the investigational use of a drug called volixibat for the treatment of pruritis (itching) associated with primary sclerosing cholangitis (PSC).

Condition:

Inflammatory bowel disease, COVID-19

Participant Requirements:

• Participants for whom vaccines are authorized for ages 13 and over with inflammatory bowel disease (IBD)
• History of chronic (more than 1 month) ulcerative colitis or Crohn’s disease
• Planned or prior receipt of any authorized vaccine against COVID-19

Summary:

This study focuses on individuals who are at least 13 years old and have inflammatory bowel disease (Crohn’s disease or ulcerative colitis). The purpose of the study is to understand the effects of COVID-19 vaccination in these patients.

Condition:

Inflammatory bowel disease

Participant Requirements:

• Diagnosis of IBD
• Family members of patients participating in the M.I.R.I.A.D. Biobank
• Control subjects without IBD

Summary:

The purpose of the M.I.R.I.A.D. Biobank is to advance the understanding of inflammatory bowel diseases (IBD) and other inflammatory disorders. The Biobank collects specimens for immediate use in research studies and maintains specimens for future use. It also gathers information about donated samples from participants' medical records. Specimens and health information are used in M.I.R.I.A.D. Biobank-supported investigations to improve the diagnosis and treatment of disease. Current and future uses of specimens may include genome sequencing, stem cell research and/or creation of cell lines.

Condition:

Gastrointestinal symptoms

Participant Requirements:

• At least 18 years old
• New patient visit with a dietician at Cedars-Sinai or University of Michigan
• Access to modern device supporting iOS (tablets, iPads, iPhones, and Android) and internet access

Summary:

This study focuses on patients who are scheduled to see a dietician at a future appointment as part of routine clinical care. The purpose of the study is to evaluate the impact of the My Nutritional Health Application. This mobile app allows individuals to maintain a food diary and track gastrointestinal (GI) symptoms through the Food and Symptoms Tracker (FAST). Researchers aim to examine the relationship between participants’ GI symptoms and food. Once participants have downloaded the app, they will be prompted to answer questions related to food intake and mental or physical symptoms that may suggest food intolerance. A member of the study team will reach out to participants to assist with any technical difficulties or to answer questions.

Condition:

Crohn’s disease

Participant Requirements:

• 18-60 years old
• Diagnosis of Crohn’s disease with minimum disease duration of 6 months with involvement of the ileum and/or colon, documented on colonoscopy
• Endoscopically confirmed, active Crohn’s disease

Summary:

This study focuses on individuals who have been diagnosed with Crohn’s disease and are at risk for fungal infection based on genetic determination. The purpose of the study is to evaluate the effects of oral posaconazole for the treatment of active Crohn’s disease in a genetically defined population.

Condition:

Inflammatory bowel disease

Participant Requirements:

• At least 18 years old
• Diagnosis of Crohn’s disease, ulcerative colitis or IBD undetermined
• Accept conditions of informed consent
• Affiliated with a participating IBD care site

Summary:

This study is designed as a program to collect health information from adults with inflammatory bowel disease (IBD) to better understand the disease and improve the quality of care for individuals living with IBD. The program will focus on a new way to manage IBD care, referred to as a dashboard, which will allow for more informed and productive communication between patients and providers.

Health information will be collected for quality improvement initiatives and research from three sources: medical records at the IBD Care Center, information that the provider enters into the dashboard, and information that the patient enters into the dashboard. Data will be maintained in a secure database.

Condition:

Crohn's disease

Participant Requirements:

• Be 18-80 years old (Where locally permissible, individuals who are 16 to <18 years old and who meet specific criteria are eligible.)
• Have confirmed diagnosis of Crohn's disease for at least 3 months prior to baseline visit
• Have Crohn's disease activity index score 220–450 at baseline

Summary:

This study focuses on individuals diagnosed with Crohn's disease and who are experiencing symptoms such as diarrhea, abdominal pain and/or a sudden and constant urge to move their bowels. The purpose of the study is to evaluate the efficacy and safety of various doses of an investigational drug called risankizumab and to determine how well it works in patients with moderate to severe Crohn's disease.

Condition:

Ulcerative colitis, Crohn's disease

Participant Requirements:

• Male or female with UC or CD between 2-17 years old at the time of group assignment for study MLN0002-2003
• Completed study MLN0002-2003 and at week 22 of the study, achieved clinical response

Summary:

This study focuses on patients who have previously participated in the MLN0002-2003 study (A Phase II, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease). Researchers will evaluate the long-term safety of a drug called vedolizumab in children who have ulcerative colitis (UC) or Crohn's disease (CD).

Condition:

Crohn's disease

Participant Requirements:

• At least 18 years old
• Documented diagnosis of Crohn’s disease (CD) confirmed by endoscopic biopsy before resection or by tissue obtained at resection.
• Planning to undergo a laparoscopic ileocecal resection with primary anastomosis within 72 hours before assignment to study group

Summary:

The purpose of this study is to evaluate the safety and tolerability of an investigational drug called TAK-018 in patients with Crohn’s disease after bowel resection. The study will also evaluate whether TAK-018 can prevent CD from recurring after surgery. TAK-018 works by blocking a type of gut bacteria that enters the bowel wall.

Condition:

Ulcerative colitis, Crohn's disease

Participant Requirements:

• Weighs ≥10 kg
• 2-17 years old, with moderately to severely active UC or CD diagnosed at least 3 months before screening

Summary:

This study focuses on children diagnosed with either Crohn’s disease (CD) or ulcerative colitis (UC) and who are between the ages of 2 and 17. The purpose of the study is to examine how a drug called vedolizumab is processed by the body in these children. Researchers also aim to evaluate whether vedolizumab is safe and effective for the treatment of UC and CD in children and to determine which dose may be best. Vedolizumab belongs to a group of proteins called antibodies, which help to reduce inflammation that can cause the symptoms in CD and UC. The use of vedolizumab in this study is investigational.

Condition:

Pancreatitis

Participant Requirements:

• 18-75 years old
• Currently hospitalized with acute pancreatitis
  
• TWEAK (screening test) alcohol consumption score of ≥3
  

Summary:

This study focuses on individuals who have been diagnosed with pancreatitis and consume alcohol. The purpose of the study is to examine health behaviors (including alcohol consumption, diet and smoking) that may contribute to the development of acute pancreatitis. Researchers aim to determine whether recent increase in alcohol consumption precipitates an attack of pancreatitis and whether the impact of alcohol is different for individuals who drink or smoke regularly.

Condition:

Diabetes, pancreatic cancer, pancreatic diseases

Participant Requirements:

• At least 40 years old; less than 85 years old
• Must have a diagnosis of one of the following:
  • New onset diabetes in subjects with pancreatic cancer (PDAC)
  • New onset diabetes in subjects with chronic pancreatitis
  • New onset diabetes in subjects without pancreatic disease 
  • Long-standing Type 2 diabetes without pancreatic disease
  • Long-standing diabetes in subjects with PDAC
  • Long-standing diabetes subjects with chronic pancreatitis
  • Non-diabetic subjects with PDAC
  • Non-diabetic subjects with chronic pancreatitis
  • Non-diabetic control subjects without pancreatic disease

Summary:

This study focuses on patients who have chronic pancreatitis, pancreatic cancer, or no known pancreas disease. It is now recognized that a small portion of the population with diabetes have an underlying problem with their pancreas, such as chronic pancreatitis (when the pancreas is swollen and irritated all the time and affected by scarring) or pancreatic cancer, as the cause of their diabetes. Currently, there is no test to identify the small number of patients who have diabetes caused by a primary problem with their pancreas. The purpose of this study is to develop a blood test to distinguish various causes of diabetes. To this end, researchers will enroll a range of patients; most have developed diabetes within the last 3 years, but the study will also enroll a small number of patients with long-term diabetes and normal blood sugars for comparison. Participants will be asked to complete a questionnaire regarding their personal and family history, and a series of blood samples will be collected prior to and for 2 hours following consumption of a liquid nutritional supplement called Boost. 

Condition

Primary biliary cholangitis

Participant Requirements:

• 18-75 years old
• Primary biliary cholangitis by at least two of the following criteria:
  • History of alkaline phosphatase above upper limit of normal (ULN) for at least 6 months
  • Positive anti-mitochondrial antibodies titers
  • Documented liver biopsy result consistent with primary biliary cholangitis (with no cirrhosis)

Summary

The purpose of this study is to evaluate whether an investigational drug called EDP-305 is safe and effective for individuals with primary biliary cholangitis (PBC), a chronic disease of the liver, in patients with or without an inadequate response to ursodiol therapy. Researchers also aim to determine the dose of study drug that works best. The study will compare the effects of EDP-305 against the effects of a placebo (inactive substance). Samples for biomarkers will also be collected. A biomarker is a biological molecule found in blood, other body fluids, or tissues that may be a sign of a condition or disease. Biomarkers can be helpful in evaluating the effectiveness and safety of a medicine. Participants will be randomly assigned to receive EDP-305 or placebo.

Condition:

Primary biliary cholangitis

Participant Requirements:

• 18-75 years old
• Definite or probable diagnosis of primary biliary cholangitis
• Individuals in whom it is safe and practical to proceed with a liver biopsy

Summary:

This study focuses on individuals who have been diagnosed with primary biliary cholangitis (PBC), a chronic liver disease resulting from progressive destruction of the liver bile ducts and buildup of bile acids leading to inflammation and scarring of the liver. The purpose of the study is to evaluate the safety and effectiveness of an investigational drug called elafibranor in patients with PBC who have inadequate response to or cannot tolerate standard therapy for PBC.

Condition:

Pancreatitis

Participant Requirements:

• Must be under 18 years old
• Must fit specific criteria for acute pancreatitis, acute recurrent pancreatitis, or chronic pancreatitis
• Participants/parents must have signed an authorization for the release of their or their child’s protected health information

Summary:

In this study, researchers will collect fluid samples, clinical data, and questionnaires from children with all types of pancreatitis. Researchers hope to use the samples and data to learn how common pancreatitis is in children, what causes pancreatitis, and how it progresses (gets worse). In so doing, researchers aim to develop better tests and treatments for the disease.

Condition:

Pancreatic ductal adenocarcinoma

Participant Requirements:

• Pancreatic cancer patients (with resectable or borderline resectable or locally advanced tumors) who will undergo neoadjuvant chemotherapy
• Able to undergo at least two sets of MRI sessions
• Access to a device that has the capability to sync to the Fitbit

Summary:

This study focuses on patients who are receiving care for non-metastatic pancreatic cancer at Cedars-Sinai. The purpose of the study is to evaluate the role of a method of magnetic resonance imaging (MRI) analysis for individuals with pancreatic ductal adenocarcinoma (PDAC).

Condition:

Pancreatic adenocarcinoma

Participant Requirements:

• At least 18 years old
• Confirmed locally advanced pancreatic adenocarcinoma
• Has at least one lesion with a diameter of at least 1.5 cm but no more than 6 cm within 6 weeks of screening

Summary:

This study focuses on patients who have pancreatic cancer that cannot be removed with surgery and who have already received standard of care treatment (including IV chemotherapy). The purpose of the study is to determine whether the use of an investigational drug called NanoPac helps kill cancer cells in patients with pancreatic cancer. Researchers also aim to identify the dose of NanoPac that is best tolerated and causes the least side effects when injected directly into the tumor in the pancreas.

NanoPac is made of very small particles of another drug called paclitaxel, which is a chemotherapy drug approved by the U.S. Food and Drug Administration for other types of cancer. The use of Nanopac in this study is investigational.

Condition:

Diabetes, hyperglycemia

Participant Requirements:

• Between 50-85 years old at the time of enrollment
• Must have hyperglycemia and/or diabetes
• Must be willing to provide blood samples (fasting) at baseline, 6, 12, and 24 months post-enrollment

Summary:

The purpose of this study is to create a large repository of blood samples and data from people with new-onset hyperglycemia and diabetes. A repository is a collection of samples from many different people that facilitates research. The study focuses on adults (50-85 years old) who have recently had one or more blood tests that indicate they may have hyperglycemia and/or diabetes.

Condition:

Pancreatic diseases

Participant Requirements:

• Patient who is or will be scheduled for a blood draw, tissue biopsy, and/or biofluid collection at Cedars-Sinai for clinical diagnostic purposes and
• Adult patient with pancreatic disease seen at Cedars-Sinai under the care of a Panc -Bank study investigator who is the patient's treating physician

Summary:

The purpose of the Pancreatic Biomarker Bank (" Panc -Bank") is to identify biomarkers that influence an individual's risk of developing pancreatic diseases. A biomarker is a biological molecule found in blood, other body fluids, or tissues that may be a sign of a condition or disease. Through the Panc -Bank, researchers also aim to discover new tests and treatments for pancreatic diseases, as well as further their understanding of these diseases.

The Panc Bank will collect patients' blood, tissue, and biofluid samples to be used for future research; these materials will be studied together with clinical information from medical records.

Condition:

Biliary disease, pancreas disease, interventional endoscopy

Key Inclusion Criteria:

• Pediatric patients who are less than 18 years old and identified as needing ERCP

Summary:

This study focuses on pediatric patients who have been identified as needing an endoscopic procedure called endoscopic retrograde cholangiopancreatography (ERCP). The purpose of the study is to gain knowledge about ERCP, which is used to diagnose and treat problems in the bile and pancreas. During this procedure, a narrow, flexible tube (endoscope) that has a video camera is utilized. Participants will be asked for permission to review medical records; additional procedures or clinic visits are not required to take part in the study. Researchers aim to learn more about the indications and safety of ERCP in pediatric patients to improve treatment and create specific guidelines for using this procedure in children.

Condition:

Pancreatitis

Participant Requirements:

• Must be between 18-75 years old at the time of enrollment

GREEN GROUP I: No Pancreas Disease Controls

• No personal history or symptoms of pancreatic disease

GREEN GROUP II: Chronic Upper Abdominal Pain of Suspected Pancreatic Origin

• Referred to a pancreas or GI clinic or admitted to the hospital for evaluation unexplained upper abdominal pain of at least 3 months in duration

YELLOW GROUP I: Indeterminate Chronic Pancreatitis (CP) with no history of Acute Pancreatitis

• Referred to a pancreas or GI clinic or admitted to the hospital for evaluation of unexplained upper abdominal pain of at least 3 months in duration

YELLOW GROUP II: Acute Pancreatitis (AP)

• History of 1 documented attack of AP in the preceding 18 months

YELLOW GROUP III: Recurrent Acute Pancreatitis (RAP)

• 2 or more documented attacks of AP separated by at least 1 month

RED GROUP: Definite Chronic Pancreatitis

• Presence of unequivocal (definite) CP and/or parenchymal and/or ductal calcifications 

Summary:

The purpose of this study is to learn about chronic pancreatitis and discover new ways to detect, treat and help prevent the disease. The study aims to determine how the diagnosis can be made earlier, why and how the disease progresses, and what genetic factors may affect the chances of developing chronic pancreatitis. Researchers also aim to learn about the natural history of chronic pancreatitis (what happens over a long period of time).

Chronic pancreatitis occurs when the pancreas is affected by inflammation and scarring. Since treatment options for advanced (end-stage) chronic pancreatitis are limited, patients with early-stage chronic pancreatitis or those at high risk of developing chronic pancreatitis are ideally suited for interventions to prevent the development of end-stage pancreatitis and its associated complications. This study aims to provide the most accurate and reliable estimates to date on disease progression and clinical events involving chronic pancreatitis. Participants will be asked to complete questionnaires and provide specimen samples, among other study procedures. Additionally, the participant’s physician and research coordinator will complete a case report form about the participant’s pancreatic history, symptoms and treatment.

Condition: 

Pancreatitis, pancreas divisum

Participant Requirements:

• At least 18 years old
• 2 or more episodes of acute pancreatitis, with each episode meeting specific criteria
• Confirmed pancreas divisum
• At least one episode of acute pancreatitis within 24 months of enrollment

Summary:

This study focuses on patients who have been diagnosed with pancreas divisum and have had at least 2 episodes of pancreatitis. The purpose of the study is to determine whether endoscopic retrograde cholangiopancreatography (ERCP) with sphincterotomy reduces the risk of pancreatitis or the number of recurrent pancreatitis episodes in patients with pancreas divisum.

Condition:

Pancreaticobiliary disorder

Participant Requirements:

• At least 18 years old
• Diagnosed with chronic biliary type abdominal pain or pancreatic pain at least three months prior to the study, in the absence of abnormal liver and pancreas chemistry or abnormal abdominal imaging
• Has average pain score of ≥3 out of 10 in numeric rating scale (NRS) for at least the average of 3 episodes each week

Summary:

The purpose of this study is to evaluate a virtual reality (VR) tool (i.e., Oculus Go, a head-mounted VR display), an over-the-counter pain relief device and remote clinical monitoring on patients with pain from pancreaticobiliary or type 3 Sphincter of Oddi Dysfunction (SOD). Researchers aim to determine whether the use of the VR intervention can improve a participant's ability to perform everyday tasks, reduce the amount of time missed from work, limit the extent to which pain interferes with a participant's life and improve overall health.

Condition:

Gastrointestinal symptoms

Participant Requirements:

• At least 18 years old
• New patient visit with a dietician at Cedars-Sinai or University of Michigan
• Access to modern device supporting iOS (tablets, iPads, iPhones, and Android) and internet access

Summary:

This study focuses on patients who are scheduled to see a dietician at a future appointment as part of routine clinical care. The purpose of the study is to evaluate the impact of the My Nutritional Health Application. This mobile app allows individuals to maintain a food diary and track gastrointestinal (GI) symptoms through the Food and Symptoms Tracker (FAST). Researchers aim to examine the relationship between participants’ GI symptoms and food. Once participants have downloaded the app, they will be prompted to answer questions related to food intake and mental or physical symptoms that may suggest food intolerance. A member of the study team will reach out to participants to assist with any technical difficulties or to answer questions.

Condition:

Visceroptosis

Participant Requirements:

• Heathy adults over 18 years old
  

Summary:

The purpose of this study is to examine how far abdominal organs drop when moving from lying flat to standing upright in patients with visceroptosis. Participants will be part of the “normal control” group (healthy people), which means that they do not have the condition or disease that is being studied.