Safety Evaluation of Fecal Microbiota Transplantation in Severe Alcoholic Hepatitis

Description

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

Alcoholic Hepatitis

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Study Overview

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Study Details

Study overview

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.

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.

Safety Evaluation of Fecal Microbiota Transplantation in Severe Alcoholic Hepatitis

Condition
Alcoholic Hepatitis
Intervention / Treatment

-

Contacts and Locations

Houston

Baylor St. Luke Medical Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Prasun Kumar Jalal,

Study Record Dates

2025-06-30