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Microbiota Transplantation

Fecal Microbiota Transplant for Alcoholic Hepatitis

Phase 1

Recruiting

Research Sponsored by Prasun Kumar Jalal

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Patients with swallowing dysfunction at risk of aspiration

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at [baseline] [12 month]

Summary

This trial will study the effects of a microbiota capsule on patients with severe alcoholic hepatitis. 50 patients will be given the capsule or a placebo, and researchers will track changes in their microbiome and health.

Who is the study for?

This trial is for men and women aged 18-75 with severe alcoholic hepatitis, recently jaundiced due to heavy drinking. They must have specific liver enzyme levels and a MELD score >15 or Maddrey DF score ≥32. Excluded are those with immune deficiencies (not from liver disease), uncontrolled infections, certain other diseases like HIV/HBV/HCV/TB, pregnant/breastfeeding individuals, drug addicts, very high-risk patients as judged by the investigator, recent major abdominal surgery recipients, cancer patients on certain treatments, those at risk of aspiration due to swallowing issues or who have non-alcohol related liver diseases.

What is being tested?

The study tests fecal microbiota transplantation (FMT) in capsule form against a placebo in patients with severe alcoholic hepatitis. It's designed to see if FMT can safely improve gut microbiome diversity when taken alongside standard care over four weeks. Participants are randomly assigned to either the FMT group or the placebo group in equal numbers.

What are the potential side effects?

Potential side effects may include gastrointestinal discomfort or infection since it involves introducing new bacteria into the body through FMT capsules. The exact side effects will be monitored closely given this is a safety evaluation study.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have trouble swallowing and might inhale food or liquids.

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I have a shunt in my body that might need long-term antibiotics if infected.

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I do not have any ongoing serious infections, sepsis, or uncontrolled bleeding in my stomach or intestines.

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I have or am at risk for GI blockage or had major belly surgery in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at [baseline] [12months]

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at [baseline] [12months]

This trial's timeline: 3 weeks for screening, Varies for treatment, and at [baseline] [12months] for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

To assess the change in gut microbiome population associated with severe alcoholic hepatitis patients from baseline in study population at 12 months.

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

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Secondary study objectives

To assess change in the Lille Model from baseline in the study population and at 12 months.

To assess change in the Lille Model from baseline in the study population at 12 weeks.

To assess change in the Lille Model from baseline in the study population at 4 weeks.

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Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Intervention ArmActive Control1 Intervention

Subjects will receive Standard of Care (SOC), based on AASLD/EASL guidelines and one dose of PRIM-DJ2727 (30 grams of stool/dose \~ 3 capsules) every day for a week followed by once weekly for 3 weeks, amounting to total 10 doses. PRIM-DJ2727 (microbiota suspension) is an intestinal microbial suspension prepared form stool obtained from carefully and thoroughly screened healthy human donors. It will be provided by University of Texas School of Public Health.

Group II: Placebo ArmPlacebo Group1 Intervention

Subjects will receive Standard of Care (SOC), based on AASLD/EASL guidelines and one dose of Placebo every day for a week followed by once weekly for 3 weeks, amounting to total 10 doses. Placebo will be identical to the investigational product but will not contain active PRIM-DJ2727.

0 / 4Eligibility criteria met