Evaluating the safety of fecal microbiota transplantation for severe alcoholic hepatitis

Fecal Microbiome Changes Characterization and Safety Evaluation After Oral Administration of Lyophilized Capsules Containing Microbiota Suspension in Severe Alcoholic Hepatitis Patients: Double Blinded, Randomized, Placebo-Controlled Study.

This study is testing whether a new treatment using fecal microbiota transplantation can help improve safety and outcomes for people with severe alcoholic hepatitis.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Baylor College of Medicine (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT05006430 on ClinicalTrials.gov

What this trial studies

This pilot study aims to assess the safety and potential benefits of fecal microbiota transplantation in patients with severe alcoholic hepatitis. It is a single-center, randomized, double-blind, placebo-controlled trial involving 50 participants who will be assigned to receive either the microbiota treatment or a placebo alongside standard care for four weeks. The study will also characterize the intestinal microbiome of these patients to understand the impact of the intervention on microbiome diversity. The goal is to explore a novel therapeutic approach for a condition that currently has limited effective treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with severe alcoholic hepatitis who meet specific clinical criteria.

Not a fit: Patients with non-alcoholic liver diseases or significant gastrointestinal issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve the management of severe alcoholic hepatitis and enhance patient outcomes.

How similar studies have performed: While the approach of fecal microbiota transplantation is novel in this context, similar studies have shown promise in other gastrointestinal conditions.

Eligibility criteria

Inclusion Criteria:

1. Any gender; male or female; aged 18- 75 years old.
2. Severe alcoholic hepatitis defined as 2.1 Onset of jaundice within prior 8 weeks. 2.2 Ongoing alcohol consumption of \>40 g/day (3 drinks) in females or \>60 g/day (4 drinks) in males for 6 months or more, with less than 60 days of abstinence before the onset of jaundice. 2.3 Aspartate aminotransferase \>50, Aspartate aminotransferase/Alanine aminotransferase ratio \> 1.5, BUT both values \<400 IU/L.

2.4 Serum total bilirubin \>3.0 mg/dl. 2.5 MELD score \>15 and/or Maddrey DF score of ≥32.

Exclusion Criteria:

1. Non-alcoholic related liver diseases.
2. Patients with swallowing dysfunction at risk of aspiration.
3. Patients at risk for or with known anatomic or functional gastrointestinal (GI) obstruction or who have undergone major intra-abdominal surgery in the last year.
4. Patients who have undergone placement of a portosystemic shunt, infection of which may require prolonged antibiotics.
5. Patients with any congenital or acquired immunodeficiency (Other than liver disease)
6. Uncontrolled infections, sepsis, or GI bleeding.
7. Presence of cancer especially patients with skin cancer who is receiving or may receive systemic chemotherapy or immunotherapy during the study period.
8. Underlying disease that might be exacerbated by proposed treatments (e.g. HCV, HBV, HIV, TB).
9. Serum creatinine \>2.5 mg/dl at presentation.
10. Pregnant and breastfeeding patients.
11. Active use drug addiction.
12. PI thinks their participation would pose a health risk e.g. patients with very severe AH with MELD score \>30 or Maddrey DF \> 60 or patient will be getting liver transplantation imminently.
13. Any other major illness/ condition that in the investigators judgment, will substantially increase the risk to the participant.

Where this trial is running

Houston, Texas

• Baylor St. Luke Medical Center — Houston, Texas, United States (Recruiting)

Conditions Alcoholic Hepatitis; Severe alcoholic hepatitis