Actively Recruiting
Safety Evaluation of Fecal Microbiota Transplantation in Severe Alcoholic Hepatitis
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
This is a single center, randomized, parallel assignment, and double-blind placebo-controlled pilot study to characterize the intestinal microbiome in patients with severe Alcoholic Hepatitis (SAH) and evaluate the safety and the trends in improvement of diversity of intestinal microbiome following administration of lyophilized capsules containing microbiota suspension from well screened health donors. The study aims to enroll 50 patients with SAH who will be randomly assigned in 1:1 where 25 patients will be assigned to receive orally administered lyophilized PRIM-DJ2727 and Standard of Care (SOC) and the other 25 patients will be assigned to receive placebo and SOC for 4 weeks.
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
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