Actively Recruiting
Safety and Microbiome Changes Study of Oral Lyophilized Fecal Microbiota Capsules in Severe Alcoholic Hepatitis Patients: A Double-Blind, Randomized, Placebo-Controlled Trial
Led by Prasun Kumar Jalal · Updated on 2025-01-23
50
Participants Needed
1
Research Sites
127 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effects of oral lyophilized capsules containing microbiota suspension (PRIM-DJ2727) in patients with severe alcoholic hepatitis (SAH). This pilot, phase 1 and 2 randomized, double-blind, placebo-controlled trial aims to characterize changes in the intestinal microbiome and assess survival and safety compared to standard care. The study addresses the limited effectiveness and side effects of current steroid treatments and explores microbiome modulation as an alternative therapy. Participants will be randomly assigned to one of two groups: one receiving PRIM-DJ2727 capsules plus standard of care, and the other receiving placebo capsules plus standard of care. The intervention lasts for 4 weeks. PRIM-DJ2727 capsules are made from stool samples of carefully screened healthy donors, containing bacteria from 10g of filtered stool, while placebo capsules are identical but without bacteria. Patients will undergo assessments including survival evaluation up to 12 months and analysis of gut microbiome changes at baseline, 4 weeks, 6 months, 9 months, and 12 months. The study involves monitoring liver function and microbiome diversity to detect trends in improvement. Safety and adverse events will be recorded, with the total participation duration extending to one year after treatment.
CONDITIONS
Official Title
Safety Evaluation of Fecal Microbiota Transplantation in Severe Alcoholic Hepatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Any gender; male or female; aged 18-75 years old.
- Severe alcoholic hepatitis with jaundice onset within prior 8 weeks.
- Ongoing alcohol consumption of more than 40 g/day (3 drinks) in females or more than 60 g/day (4 drinks) in males for at least 6 months, with less than 60 days of abstinence before jaundice.
- Aspartate aminotransferase greater than 50, AST/ALT ratio greater than 1.5, but both less than 400 IU/L.
- Serum total bilirubin greater than 3.0 mg/dl.
- MELD score greater than 15 and/or Maddrey DF score of 32 or higher.
You will not qualify if you...
- Non-alcoholic related liver diseases.
- Swallowing dysfunction with risk of aspiration.
- Known or suspected gastrointestinal obstruction or major intra-abdominal surgery within the last year.
- Placement of portosystemic shunt with risk of infection requiring prolonged antibiotics.
- Congenital or acquired immunodeficiency other than liver disease.
- Uncontrolled infections, sepsis, or gastrointestinal bleeding.
- Presence of cancer, especially skin cancer receiving or expected to receive chemotherapy or immunotherapy.
- Underlying diseases that may worsen with treatment (e.g., HCV, HBV, HIV, TB).
- Serum creatinine greater than 2.5 mg/dl at presentation.
- Pregnant or breastfeeding patients.
- Active drug addiction.
- Very severe alcoholic hepatitis with MELD score over 30 or Maddrey DF over 60 or imminent liver transplantation.
- Any other major illness judged by investigators to substantially increase risk to the participant.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Baylor St. Luke Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here