Alcoholic HepatitisPhase 1/2NCT05006430
Safety Evaluation of Fecal Microbiota Transplantation in Severe Alcoholic Hepatitis
A Phase 1/2 study testing Fecal Microbiota Transplantation in people with Alcoholic Hepatitis, run by Prasun Kumar Jalal at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Alcoholic Hepatitis
- What is being tested?
- Fecal Microbiota Transplantation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2023to 30 Jun 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any gender; male or female; aged 18- 75 years old.
- Severe alcoholic hepatitis defined as 2.1 Onset of jaundice within prior 8 weeks. 2.2 Ongoing alcohol consumption of >40 g/day (3 drinks) in females or >60 g/day (4 drinks) in males for 6 months or more, with less than 60 days of abstinence before the onset of jaundice. 2.3 Aspartate aminotransferase >50, Aspartate aminotransferase/Alanine aminotransferase ratio > 1.5, BUT both values <400 IU/L.
- 2.4 Serum total bilirubin >3.0 mg/dl. 2.5 MELD score >15 and/or Maddrey DF score of ≥32.
Who cannot join
- Non-alcoholic related liver diseases.
- Patients with swallowing dysfunction at risk of aspiration.
- Patients at risk for or with known anatomic or functional gastrointestinal (GI) obstruction or who have undergone major intra-abdominal surgery in the last year.
- Patients who have undergone placement of a portosystemic shunt, infection of which may require prolonged antibiotics.
- Patients with any congenital or acquired immunodeficiency (Other than liver disease)
- Uncontrolled infections, sepsis, or GI bleeding.
Show all 13Show fewer
- Presence of cancer especially patients with skin cancer who is receiving or may receive systemic chemotherapy or immunotherapy during the study period.
- Underlying disease that might be exacerbated by proposed treatments (e.g. HCV, HBV, HIV, TB).
- Serum creatinine >2.5 mg/dl at presentation.
- Pregnant and breastfeeding patients.
- Active use drug addiction.
- PI thinks their participation would pose a health risk e.g. patients with very severe AH with MELD score >30 or Maddrey DF > 60 or patient will be getting liver transplantation imminently.
- Any other major illness/ condition that in the investigators judgment, will substantially increase the risk to the participant.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Baylor St. Luke Medical Center
Houston, Texas, 77030
Prasun K. Jalal, MD, 832-355-1424, Jalal@bcm.edu
About this study
Official title: Fecal Microbiome Changes Characterization and Safety Evaluation After Oral Administration of Lyophilized Capsules Containing Microbiota Suspension in Severe Alcoholic Hepatitis Patients: Double Blinded, Randomized, Placebo-Controlled Study.
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.
Read the detailed description
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.
- Conditions
- Alcoholic Hepatitis
- Being tested
- Fecal Microbiota Transplantation, Placebo
- Keywords
- Severe alcoholic hepatitis
- Medical subject headings
- Hepatitis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota TransplantationBiological
Also called (PRIM-DJ2727), FMT
It's an intestinal microbial suspension prepared form stool obtained from carefully and thoroughly screened healthy human donors.
PlaceboOther
Placebo will be identical to the investigational product but will not contain fecal material.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Active comparator | 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. Receives: Biological: Fecal Microbiota Transplantation |
| Placebo Arm | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: [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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At [Baseline] [12months]
Secondary outcomes (20)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At [Baseline] [12 month]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start21 Jan 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic HepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prasun Kumar Jalal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prasun Kumar Jalal, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006430
- Sponsor's protocol ID
- H-43752
- Status last verified
- Aug 2024
- First submitted
- 4 Jun 2021
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiome Changes Characterization and Safety Evaluation After Oral Administration of Lyophilized Capsules Containing Microbiota Suspension in Severe Alcoholic Hepatitis Patients: Double Blinded, Randomized, Placebo-Controlled Study.
- ClinicalTrials.gov ID
- NCT05006430
- Acronym / sponsor ID
- H-43752
- Conditions
- Alcoholic Hepatitis
- Keywords
- Severe alcoholic hepatitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Prasun Kumar JalalUniversity, hospital or other
- Study start
- 21 Jan 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Active comparator | Biological: Fecal Microbiota TransplantationSubjects 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. |
| Placebo Arm | Placebo comparator | Other: PlaceboSubjects 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Any gender; male or female; aged 18- 75 years old.
- Severe alcoholic hepatitis defined as 2.1 Onset of jaundice within prior 8 weeks. 2.2 Ongoing alcohol consumption of >40 g/day (3 drinks) in females or >60 g/day (4 drinks) in males for 6 months or more, with less than 60 days of abstinence before the onset of jaundice. 2.3 Aspartate aminotransferase >50, Aspartate aminotransferase/Alanine aminotransferase ratio > 1.5, BUT both values <400 IU/L.
- 2.4 Serum total bilirubin >3.0 mg/dl. 2.5 MELD score >15 and/or Maddrey DF score of ≥32.
Key exclusion criteria (13 listed)
- Non-alcoholic related liver diseases.
- Patients with swallowing dysfunction at risk of aspiration.
- Patients at risk for or with known anatomic or functional gastrointestinal (GI) obstruction or who have undergone major intra-abdominal surgery in the last year.
- Patients who have undergone placement of a portosystemic shunt, infection of which may require prolonged antibiotics.
- Patients with any congenital or acquired immunodeficiency (Other than liver disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal Microbiota TransplantationAlso: (PRIM-DJ2727), FMTIt's an intestinal microbial suspension prepared form stool obtained from carefully and thoroughly screened healthy human donors. | Biological | Intervention Arm |
| PlaceboPlacebo will be identical to the investigational product but will not contain fecal material. | Other | Placebo Arm |
Primary outcome
To Assess survival in patients with severe alcoholic hepatitis receiving PRIM-DJ2727 capsules in comparison to standard of care.
Time frame: [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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At [Baseline] [12months]
Microbiome will be characterized at baseline and at 12 months in terms of predominant genera and number of each genus population.
20 secondary outcomes
To assess change in the prognostic scores of Model for End Stage Liver Disease (MELD) from baseline in the study population 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.
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.
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.
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.
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.
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.
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.
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.
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.
Time frame: At [Baseline] [12 month]
To assess change in the Lille Model from baseline in the study population 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.
Time frame: At [Baseline] [12 weeks]
To assess change in the Lille Model from baseline in the study population 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.
Time frame: At [Baseline] [ 9 month]
To assess change in the Lille Model from baseline in the study population 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.
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.
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.
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.
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.
Time frame: At [Baseline] [12 month]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fecal Microbiota Transplantation in people with Alcoholic Hepatitis, run by Prasun Kumar Jalal at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Assess survival in patients with severe alcoholic hepatitis receiving PRIM-DJ2727 capsules in comparison to standard of care. (time frame: [Day1 to 12 month]). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.