Safety Evaluation of Fecal Microbiota Transplantation in Severe Alcoholic Hepatitis

ConditionAlcoholic Hepatitis

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorPrasun Kumar Jalal

About this trial

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.

Eligibility criteria

Qualifiers

Any gender; male or female; aged 18- 75 years old.

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.

Disqualifiers

Non-alcoholic related liver diseases.

Patients with swallowing dysfunction at risk of aspiration.

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.

Patients who have undergone placement of a portosystemic shunt, infection of which may require prolonged antibiotics.

Trial design

Treatments tested in this trial

Fecal Microbiota Transplantation
Placebo

Treatment groups

50 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Prasun Kumar Jalal

Lead sponsor

Baylor College of Medicine

Sponsor institution

Source ClinicalTrials.gov