A Phase 1/2 interventional study of Fecal Microbiota Transplantation and Placebo in Alcoholic Hepatitis, sponsored by Prasun Kumar Jalal. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-01-23.
Sponsored by Prasun Kumar Jalal · Phase 1/2, Interventional, and Other
Among 38 studies in Hepatitis, Alcoholic with a site in United States — 7 open to participants now, 7 under way, 1 of them phase 3. Hepatitis, Alcoholic · United States.
Among the 38 studies in Hepatitis, Alcoholic with a site in United States, this one is the 13th largest by planned enrollment of the 28 interventional ones that give a count, is the only one that started in 2023, is one of 2 in phase 1/2, and was the 32nd registered.
113 studies on the registry are indexed under Hepatitis, Alcoholic; 24 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 80 interventional studies indexed under Hepatitis, Alcoholic.
Browse Hepatitis, Alcoholic studies →7 of the 38 studies in Hepatitis, Alcoholic with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 17 Hepatitis, Alcoholic studies recruiting now, 9 (53%) set no upper age limit and 8 (47%) stop at 75 or younger; 0 take children under 18; 2 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →38 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 1 started in 2023.
Median enrollment 44 across the 28 interventional studies, 327 across the 10 observational. Of the 28 that completed or were terminated, 17 (61%) have results posted.
15 of 38 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Prasun Kumar Jalal as lead sponsor.
Prasun Kumar Jalal has 1 study filed under Hepatitis, Alcoholic — fewer than ten, so there is no comparison to draw.
2 of the studies in Hepatitis, Alcoholic with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07428538Phase 3Bausch Health Americas, Inc.Study to Evaluate the Safety and Efficacy of Larsucosterol in Participants With Alcohol-associated Hepatitis (AH) | 2027-11 |
| NCT03845205Johns Hopkins UniversityAlcohol Treatment Outcomes Following Early vs. Standard Liver Transplant for SAH | 2027-06 |
Among the 38 studies in Hepatitis, Alcoholic with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Background:
Alcoholic hepatitis (AH) is a major public health problem in the United States, caused by chronic alcohol consumption of more than 40-60 g/day. Approximately 5 million Americans are diagnosed with AH, contributing to 5% of US annual mortality. A 28-day mortality rate had been reported in 30 to 50% of patients with AH. Steroid therapy has been the mainstay treatment of patients with severe AH for the last 50 years. Yet, such treatment hasn't clearly result in improvement of liver indices and survival rates among AH patients. Moreover, the use of prednisolone was associated with significant side effects and has several contraindications. Alternative therapeutic approaches have been explored but with lack of effectiveness. On the other side, shortage of organs and cost for liver transplantation are major barriers for liver transplantation in patients with AH.
There is a growing evidence suggesting that gut-derived bacterial endotoxins may play a role in alcohol-induced tissue injury and liver failure among heavy alcohol drinkers. This could be attributable to two factors: The first is decreased gastrointestinal motility. Ethanol can alter intestinal permeability by disrupting intercellular tight junctions and lead to GUT leak and translocation of the microbes. The second factor explain the association between microbiota and alcohol liver diseases is down-regulation of antimicrobial peptides induced by alterations in host immune responses in alcohol drinkers. One experimental study compared alcohol-sensitive mice (ASM) to alcohol-resistant mice (ARM). The study showed that ASM have reduced Bacteroidetes and increased level of Actinobacteria and Firmicutes and that performing fecal microbiota transplantation (FMT) from ARM to ASM yielded protection against Bacteroidetes depletion and against the alcohol-induced steatosis in ASM.
Over the last few years, multiple studies have shown that FMT is safe and more effective in treatment of recurrent clostridium difficile than the standard medical treatment. The successful use of FMT in recurrent C. difficile, lead to multiple exploratory studies assessing safety and efficacy of FMT in multiple diseases especially gastrointestinal disorders, including Primary Sclerosing Cholangitis (PSC), Inflammatory Bowel Diseases (IBD), Liver cirrhosis and Hepatic Encephalopathy. These studies showed that FMT was safe and showed signs of effectiveness that requires larger Randomized control trials (RCTs) to confirm these findings. A Recent study by Indian investigators showed that modulation of intestinal microbiota has shown to improve survival in patients with severe AH. However, the study had multiple limitations, including absence of randomization, limited number of biochemical parameters and prognostic scores used, use of Nasoduodenal tube to deliver FMT and the lack of detail profiling of intestinal microbiome.
Investigational Agent:
PRIM-DJ2727(microbiota suspension)is an intestinal microbial suspension prepared form stool obtained from carefully and thoroughly screened healthy human donors. PRIM-DJ2727 is prepared from a standard amount of healthy human stool mixed with 0.85%NaCI(normal saline) and 2% mannitol. Microbiota from a single donor will be screened before lyophilization and encapsulation. The lyophilized capsules given for each treatment contain bacteria from 10g Filtered stool. Placebo will be identical to the investigational product but will not contain intestinal bacteria.
This is a single center, randomized, parallel assignment, and double-blind placebo-controlled pilot study to be conducted in subjects with severe AH. Subjects with clinical diagnosis of severe alcoholic hepatitis (SAH) based on recommendation From the NIAAA Alcoholic Hepatitis Consortia criteria will be eligible.
After screening, the investigators aim 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.
This study is considered Pilot study due to small sample size as the investigators are using this Phase I study to assess the safety of the PRIM-DJ2727 Capsules in patients with Alcoholic hepatitis and to provide enough data to design and prepare for Phase II trial.
A formal sample size has not been calculated as this study is not powered to establish significance. This is a pilot study aimed at characterizing the intestinal microbiome in patients with severe AH and evaluate the safety and the trends in improvement of diversity of intestinal microbiome following administration of lyophilized capsules containing microbiota suspension (PRIM-DJ2727 capsules) from well screened health donors.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
2.4 Serum total >3.0 mg/dl. 2.5 MELD score >15 and/or Maddrey DF score of ≥32.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biological: Fecal Microbiota Transplantation
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.
Other: Placebo
It's an intestinal microbial suspension prepared form stool obtained from carefully and thoroughly screened healthy human donors.
Also known as: (PRIM-DJ2727), FMT
Placebo will be identical to the investigational product but will not contain fecal material.
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]
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]
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]
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]
To assess the change in gut microbiome population associated with severe alcoholic hepatitis patients from baseline in study population at 12 months.
Microbiome will be characterized at baseline and at 12 months in terms of predominant genera and number of each genus population.
Time frame: At [Baseline] [12months]
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]
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]
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]
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]
To assess change in the prognostic scores of Model for End Stage Liver Disease (MELD) from baseline in the study population at 12 months.
MELD score will be reported at baseline and at 12 months.
Time frame: At [Baseline] [12 months]
To assess change in the Maddrey's Discriminant Function (Maddrey DF) from baseline in the study population at 4 weeks.
Maddery's Discriminant Function (Maddrey DF) score will be reported at baseline, and at 4 weeks.
Time frame: At [Baseline] [4 weeks]
To assess change in the Maddrey's Discriminant Function (Maddrey DF) from baseline in the study population at 12 weeks.
Maddery's Discriminant Function (Maddrey DF) score will be reported at baseline and at 12 weeks.
Time frame: At [Baseline] [12 weeks]
To assess change in the Maddrey's Discriminant Function (Maddrey DF) from baseline in the study population at 6 months.
Maddery's Discriminant Function (Maddrey DF) score will be reported at baseline, 6 months.
Time frame: At [Baseline] [6 month]
To assess change in the Maddrey's Discriminant Function (Maddrey DF) from baseline in the study population at 9 months.
Maddery's Discriminant Function (Maddrey DF) score will be reported at baseline and at 9 months.
Time frame: At [Baseline] [ 9 month]
To assess change in the Maddrey's Discriminant Function (Maddrey DF) from baseline in the study population at 12 months.
Maddery's Discriminant Function (Maddrey DF) score will be reported at baseline and at 12 months.
Time frame: At [Baseline] [12 month]
To assess change in the Lille Model from baseline in the study population at 4 weeks.
Lille score will be reported at baseline and at 4 weeks.
Time frame: At [Baseline] [4 weeks]
To assess change in the Lille Model from baseline in the study population at 12 weeks.
Lille score will be reported at baseline and at12 weeks.
Time frame: At [Baseline] [12 weeks]
To assess change in the Lille Model from baseline in the study population at 6 months.
Lille score will be reported at baseline and at 6 months.
Time frame: At [Baseline] [6 month]
To assess change in the Lille Model from baseline in the study population at 9 months.
Lille score will be reported at baseline and at 9 months.
Time frame: At [Baseline] [ 9 month]
To assess change in the Lille Model from baseline in the study population and at 12 months.
Lille score will be reported at baseline and at 12 months.
Time frame: At [Baseline] [12 month]
To assess change in the prognostic scores of Model for Glasgow Alcoholic Hepatitis Score (GAHS) from baseline in the study population at 4 weeks.
Glasgow Alcoholic Hepatitis Score (GAHS) will be reported at baseline and at 4 weeks.
Time frame: At [Baseline] [4 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.
Glasgow Alcoholic Hepatitis Score (GAHS) will be reported at baseline, and at 12 weeks.
Time frame: At [Baseline] [12 weeks]
To assess change in the prognostic scores of Model for Glasgow Alcoholic Hepatitis Score (GAHS) from baseline in the study population at 6 months.
Glasgow Alcoholic Hepatitis Score (GAHS) will be reported at baseline and at 6 months.
Time frame: At [Baseline] [6 month]
To assess change in the prognostic scores of Model for Glasgow Alcoholic Hepatitis Score (GAHS) from baseline in the study population at 9 months.
Glasgow Alcoholic Hepatitis Score (GAHS) will be reported at baseline and at 9 months.
Time frame: At [Baseline] [ 9 month]
To assess change in the prognostic scores of Model for Glasgow Alcoholic Hepatitis Score (GAHS) from baseline in the study population at 12 months.
Glasgow Alcoholic Hepatitis Score (GAHS) will be reported at baseline and at 12 months.
Time frame: At [Baseline] [12 month]
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jan 2023 (actual). Primary completion is estimated for Jun 2025, 29 months after the start.
How these figures are worked out, and which studies are left out of them.
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