Intervention Arm for Hepatitis A

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Hepatitis A+3 More
Fecal Microbiota Transplantation - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Hepatitis A
  • Alcoholic Hepatitis (AH)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

5 Primary · 20 Secondary · Reporting Duration: At [Baseline] [12 month]

Month 9
To assess change in the Lille Model from baseline in the study population at 9 months.
To assess change in the Maddrey's Discriminant Function (Maddrey DF) from baseline in the study population at 9 months.
To assess change in the prognostic scores of Model for Glasgow Alcoholic Hepatitis Score (GAHS) from baseline in the study population at 9 months.
At [Baseline] [12 month]
To assess change in the Lille Model from baseline in the study population and at 12 months.
To assess change in the Maddrey's Discriminant Function (Maddrey DF) from baseline in the study population at 12 months.
To assess change in the prognostic scores of Model for Glasgow Alcoholic Hepatitis Score (GAHS) from baseline in the study population at 12 months.
At [Baseline] [12 months]
To assess change in the prognostic scores of Model for End Stage Liver Disease (MELD) from baseline in the study population at 12 months.
At [Baseline] [12 weeks]
To assess change in the Lille Model from baseline in the study population at 12 weeks.
To assess change in the Maddrey's Discriminant Function (Maddrey DF) from baseline in the study population at 12 weeks.
To assess change in the prognostic scores of Model for End Stage Liver Disease (MELD) from baseline in the study population at 12 weeks.
To assess change in the prognostic scores of Model for Glasgow Alcoholic Hepatitis Score (GAHS) from baseline in the study population at 12 weeks.
At [Baseline] [12months]
To assess the change in gut microbiome population associated with severe alcoholic hepatitis patients from baseline in study population at 12 months.
At [Baseline] [4 weeks]
To assess change in the Lille Model from baseline in the study population at 4 weeks.
To assess change in the Maddrey's Discriminant Function (Maddrey DF) from baseline in the study population at 4 weeks.
To assess change in the prognostic scores of Model for End Stage Liver Disease (MELD) from baseline in the study population at 4 weeks.
To assess change in the prognostic scores of Model for Glasgow Alcoholic Hepatitis Score (GAHS) from baseline in the study population at 4 weeks.
To assess the change in gut microbiome population associated with severe alcoholic hepatitis patients from baseline in study population at 4 weeks.
At [Baseline] [6 month]
To assess change in the Lille Model from baseline in the study population at 6 months.
To assess change in the Maddrey's Discriminant Function (Maddrey DF) from baseline in the study population at 6 months.
To assess change in the prognostic scores of Model for Glasgow Alcoholic Hepatitis Score (GAHS) from baseline in the study population at 6 months.
At [Baseline] [6 months]
To assess change in the prognostic scores of Model for End Stage Liver Disease (MELD) from baseline in the study population at 6 months.
To assess the change in gut microbiome population associated with severe alcoholic hepatitis patients from baseline in study population at 6 months.
At [Baseline] [9 months]
To assess change in the prognostic scores of Model for End Stage Liver Disease (MELD) from baseline in the study population at 9 months.
To assess the change in gut microbiome population associated with severe alcoholic hepatitis patients from baseline in study population at 9 months.
[Day1 to 12 month]
To Assess survival in patients with severe alcoholic hepatitis receiving PRIM-DJ2727 capsules in comparison to standard of care.

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Intervention Arm
1 of 2
Placebo Arm
1 of 2
Active Control
Non-Treatment Group

50 Total Participants · 2 Treatment Groups

Primary Treatment: Intervention Arm · Has Placebo Group · Phase 1

Intervention Arm
Biological
ActiveComparator Group · 1 Intervention: Fecal Microbiota Transplantation · Intervention Types: Biological
Placebo Arm
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at [baseline] [12 month]

Who is running the clinical trial?

Prasun Kumar JalalLead Sponsor

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 14th, 2021

Last Reviewed: October 23rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.