Fecal Microbiota Transplantation for Severe Alcoholic Hepatitis
This study is looking at a treatment called Fecal Microbiota Transplantation (FMT) for people with severe alcoholic hepatitis (a serious liver condition caused by heavy alcohol use). You would receive capsules containing a suspension of healthy gut bacteria (PRIM-DJ2727) or a placebo (an inactive capsule that looks the same) for four weeks, along with your usual care. Researchers want to see if PRIM-DJ2727 can improve survival and change the gut bacteria in people aged 18 to 75 with severe alcoholic hepatitis. To join, you must have had jaundice (yellowing of the skin) within the past 8 weeks and have consumed a certain amount of alcohol before that.
- Study design
- This is a randomized, double-blind study involving 50 participants. Half will receive PRIM-DJ2727 and the other half will receive a placebo.
- What's involved
- You would receive either PRIM-DJ2727 capsules or a placebo for 4 weeks. Your gut microbiome will be checked at the start, 4 weeks, and 6 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your survival will be assessed for up to 12 months after starting the study. Your gut microbiome will be checked at 4 weeks and 6 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Safety Evaluation of Fecal Microbiota Transplantation in Severe Alcoholic Hepatitis
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- To Assess survival in patients with severe alcoholic hepatitis receiving PRIM-DJ2727 capsules in comparison to standard of care.[Day1 to 12 month]
PRIM-DJ2727 is given orally at dose of 30 gm once daily for a week then, once weekly for 3 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] [4 weeks]
Microbiome will be characterized at baseline and at 4 weeks in terms of predominant genera and number of each genus population.
- To assess the change in gut microbiome population associated with severe alcoholic hepatitis patients from baseline in study population at 6 months.At [Baseline] [6 months]
Microbiome will be characterized at baseline and at 6 months in terms of predominant genera and number of each genus population.
- To assess the change in gut microbiome population associated with severe alcoholic hepatitis patients from baseline in study population at 9 months.At [Baseline] [9 months]
Microbiome will be characterized at baseline and at 9 months in terms of predominant genera and number of each genus population.
- To assess the change in gut microbiome population associated with severe alcoholic hepatitis patients from baseline in study population at 12 months.At [Baseline] [12months]
Microbiome will be characterized at baseline and at 12 months in terms of predominant genera and number of each genus population.