NCT05006430 Safety Evaluation of Fecal Microbiota Transplantation in Severe Alcoholic Hepatitis
| NCT ID | NCT05006430 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Prasun Kumar Jalal |
| Condition | Alcoholic Hepatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-01-21 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2023-01-21 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Frequently Asked Questions
Who can join the NCT05006430 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Alcoholic Hepatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05006430 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05006430 currently recruiting?
Yes, NCT05006430 is actively recruiting participants. Visit ClinicalTrials.gov or contact Prasun Kumar Jalal to inquire about joining.
Where is the NCT05006430 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT05006430 clinical trial?
NCT05006430 is sponsored by Prasun Kumar Jalal. The trial plans to enroll 50 participants.