Recruiting
Phase 1
Phase 2

Fecal Microbiota Transplantation

Sponsor:

Prasun Kumar Jalal

Code:

NCT05006430

Conditions

Alcoholic Hepatitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Fecal Microbiota Transplantation

Placebo

Study Details

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.

Conditions

Alcoholic Hepatitis

Study ID

NCT05006430

Start date

Jan 21, 2023

Status verified date

Aug, 2024

Completion date

Jun 30, 2025

Anticipated

Primary completion date

Jun 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Fecal Microbiota Transplantation

It's an intestinal microbial suspension prepared form stool obtained from carefully and thoroughly screened healthy human donors.

Placebo

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

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] ]
  • 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] ]
  • 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] ]
  • 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] ]
  • 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] ]

Central Contacts and Locations

Locations

Baylor St. Luke Medical Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Prasun K. Jalal, MD

832-355-1424Jalal@bcm.edu

More Information

Sponsor

Prasun Kumar Jalal

Last update posted

Jan 23, 2025

Last verified

Aug, 2024

Keywords

  • Severe alcoholic hepatitis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Prasun Kumar Jalal on 2025-01-23.