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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at [baseline] [12 month]

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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.

+2 more

Secondary outcome measures

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Prasun Kumar JalalLead Sponsor

Media Library

Fecal Microbiota Transplantation (Microbiota Transplantation) Clinical Trial Eligibility Overview. Trial Name: NCT05006430 — Phase 1

Alcoholic Hepatitis Research Study Groups: Intervention Arm, Placebo Arm

Alcoholic Hepatitis Clinical Trial 2023: Fecal Microbiota Transplantation Highlights & Side Effects. Trial Name: NCT05006430 — Phase 1

Fecal Microbiota Transplantation (Microbiota Transplantation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05006430 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are actively participating in this experiment?

"Indeed, the information on clinicaltrials.gov ascertains that this research is actively seeking participants. The first posting for this trial was made on July 25th 2022 with subsequent updates also taking place then; 50 patients are needed from a single centre."

Answered by AI

Has the Intervention Arm earned clearance from regulators?

"Limited evidence supports the safety and efficacy of Intervention Arm, so it was awarded a score of 1."

Answered by AI

Are participants of all ages eligible for this scientific experiment?

"According to the required qualifications for this clinical research, participants must be aged 18 or above and no older than 75."

Answered by AI

Who is the ideal target demographic for this trial?

"Candidates for this medical trial must be afflicted with hepatitis A and aged between 18 and 75. This clinical study is enrolling a maximum of 50 patients."

Answered by AI

What goals is this trial aiming to accomplish?

"This clinical trial's primary purpose is to track the alteration of gut microbiome in patients with severe alcoholic hepatitis at a 6 month interval. Secondary objectives involve evaluating changes in prognostic scores, such as Model for End Stage Liver Disease (MELD) and Glasgow Alcoholic Hepatitis Score (GAHS), over 12 weeks and 9 months respectively."

Answered by AI

Is this medical trial actively seeking participants?

"As documented on the clinicaltrials.gov website, enrollment for this trial is currently open. The original post was made public on July 25th 2022 and has since been amended on the same date."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety Evaluation of Fecal Microbiota Transplantation in Severe Alcoholic Hepatitis

Prasun Kumar Jalal 2023. "Safety Evaluation of Fecal Microbiota Transplantation in Severe Alcoholic Hepatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05006430.

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