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Safety Evaluation of Fecal Microbiota Transplantation in Severe Alcoholic Hepatitis

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ClinicalTrials.gov Identifier: NCT05006430
Recruitment Status : Not yet recruiting
First Posted : August 16, 2021
Last Update Posted : August 16, 2021
Sponsor:
Information provided by (Responsible Party):
Prasun Kumar Jalal, Baylor College of Medicine

Brief 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 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.

Condition or disease Intervention/treatment Phase
Alcoholic Hepatitis Biological: Fecal Microbiota Transplantation Other: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
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.
Estimated Study Start Date : October 30, 2021
Estimated Primary Completion Date : October 30, 2022
Estimated Study Completion Date : October 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Intervention Arm

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
It's an intestinal microbial suspension prepared form stool obtained from carefully and thoroughly screened healthy human donors.
Other Names:
  • (PRIM-DJ2727)
  • FMT

Placebo Comparator: Placebo Arm

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
Placebo will be identical to the investigational product but will not contain fecal material.




Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. 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] ]
    MELD score will be reported at baseline and at 4 weeks

  2. 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] ]
    MELD score will be reported at baseline and at 12 weeks.

  3. 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] ]
    MELD score will be reported at baseline and at 6 months.

  4. 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] ]
    MELD score will be reported at baseline and at 9 months.

  5. 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] ]
    MELD score will be reported at baseline and at 12 months.

  6. 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] ]
    Maddery's Discriminant Function (Maddrey DF) score will be reported at baseline, and at 4 weeks.

  7. 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] ]
    Maddery's Discriminant Function (Maddrey DF) score will be reported at baseline and at 12 weeks.

  8. 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] ]
    Maddery's Discriminant Function (Maddrey DF) score will be reported at baseline, 6 months.

  9. 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] ]
    Maddery's Discriminant Function (Maddrey DF) score will be reported at baseline and at 9 months.

  10. 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] ]
    Maddery's Discriminant Function (Maddrey DF) score will be reported at baseline and at 12 months.

  11. To assess change in the Lille Model from baseline in the study population at 4 weeks. [ Time Frame: At [Baseline] [4 weeks] ]
    Lille score will be reported at baseline and at 4 weeks.

  12. To assess change in the Lille Model from baseline in the study population at 12 weeks. [ Time Frame: At [Baseline] [12 weeks] ]
    Lille score will be reported at baseline and at12 weeks.

  13. To assess change in the Lille Model from baseline in the study population at 6 months. [ Time Frame: At [Baseline] [6 month] ]
    Lille score will be reported at baseline and at 6 months.

  14. To assess change in the Lille Model from baseline in the study population at 9 months. [ Time Frame: At [Baseline] [ 9 month] ]
    Lille score will be reported at baseline and at 9 months.

  15. To assess change in the Lille Model from baseline in the study population and at 12 months. [ Time Frame: At [Baseline] [12 month] ]
    Lille score will be reported at baseline and at 12 months.

  16. 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] ]
    Glasgow Alcoholic Hepatitis Score (GAHS) will be reported at baseline and at 4 weeks.

  17. 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] ]
    Glasgow Alcoholic Hepatitis Score (GAHS) will be reported at baseline, and at 12 weeks.

  18. 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] ]
    Glasgow Alcoholic Hepatitis Score (GAHS) will be reported at baseline and at 6 months.

  19. 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] ]
    Glasgow Alcoholic Hepatitis Score (GAHS) will be reported at baseline and at 9 months.

  20. 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] ]
    Glasgow Alcoholic Hepatitis Score (GAHS) will be reported at baseline and at 12 months.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Any gender; male or female; aged 18- 75 years old.
  2. 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.

Exclusion Criteria:

  1. Non-alcoholic related liver diseases.
  2. Patients with swallowing dysfunction at risk of aspiration.
  3. 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.
  4. Patients who have undergone placement of a portosystemic shunt, infection of which may require prolonged antibiotics.
  5. Patients with any congenital or acquired immunodeficiency (Other than liver disease)
  6. Uncontrolled infections, sepsis, or GI bleeding.
  7. Presence of cancer especially patients with skin cancer who is receiving or may receive systemic chemotherapy or immunotherapy during the study period.
  8. Underlying disease that might be exacerbated by proposed treatments (e.g. HCV, HBV, HIV, TB).
  9. Serum creatinine >2.5 mg/dl at presentation.
  10. Pregnant and breastfeeding patients.
  11. Active use drug addiction.
  12. 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.
  13. Any other major illness/ condition that in the investigators judgment, will substantially increase the risk to the participant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05006430


Locations
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United States, Texas
Baylor St. Luke Medical Center
Houston, Texas, United States, 77030
Contact: Prasun K. Jalal, MD    832-355-1424    Jalal@bcm.edu   
Sponsors and Collaborators
Prasun Kumar Jalal
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Responsible Party: Prasun Kumar Jalal, Assistant Professor of Medicine-Hepatology, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT05006430    
Other Study ID Numbers: H-43752
First Posted: August 16, 2021    Key Record Dates
Last Update Posted: August 16, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prasun Kumar Jalal, Baylor College of Medicine:
Severe alcoholic hepatitis
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis
Hepatitis, Alcoholic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders