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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Fecal Microbiota Transplantation

    Biological/Vaccine

    It's an intestinal microbial suspension prepared form stool obtained from carefully and thoroughly screened healthy human donors.

  • Placebo

    Other intervention

    Placebo will be identical to the investigational product but will not contain fecal material.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Intervention ArmActive comparator 1 intervention
Group B: Placebo ArmPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

To Assess survival in patients with severe alcoholic hepatitis receiving PRIM-DJ2727 capsules in comparison to standard of care.

PRIM-DJ2727 is given orally at dose of 30 gm once daily for a week then, once weekly for 3 weeks

Time frame
[Day1 to 12 month]
2

To assess the change in gut microbiome population associated with severe alcoholic hepatitis patients from baseline in study population at 4 weeks.

Microbiome will be characterized at baseline and at 4 weeks in terms of predominant genera and number of each genus population.

Time frame
At [Baseline] [4 weeks]
3

To assess the change in gut microbiome population associated with severe alcoholic hepatitis patients from baseline in study population at 6 months.

Microbiome will be characterized at baseline and at 6 months in terms of predominant genera and number of each genus population.

Time frame
At [Baseline] [6 months]
4

To assess the change in gut microbiome population associated with severe alcoholic hepatitis patients from baseline in study population at 9 months.

Microbiome will be characterized at baseline and at 9 months in terms of predominant genera and number of each genus population.

Time frame
At [Baseline] [9 months]

Secondary outcomes

1

To assess change in the prognostic scores of Model for End Stage Liver Disease (MELD) from baseline in the study population at 4 weeks.

MELD score will be reported at baseline and at 4 weeks

Time frame
At [Baseline] [4 weeks]
2

To assess change in the prognostic scores of Model for End Stage Liver Disease (MELD) from baseline in the study population at 12 weeks.

MELD score will be reported at baseline and at 12 weeks.

Time frame
At [Baseline] [12 weeks]
3

To assess change in the prognostic scores of Model for End Stage Liver Disease (MELD) from baseline in the study population at 6 months.

MELD score will be reported at baseline and at 6 months.

Time frame
At [Baseline] [6 months]
4

To assess change in the prognostic scores of Model for End Stage Liver Disease (MELD) from baseline in the study population at 9 months.

MELD score will be reported at baseline and at 9 months.

Time frame
At [Baseline] [9 months]

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Prasun Kumar Jalal

Lead sponsor

Baylor College of Medicine

Sponsor institution

Source ClinicalTrials.gov
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