NCT05006430 · Prasun Kumar Jalal
Safety Evaluation of Fecal Microbiota Transplantation in Severe Alcoholic Hepatitis
What this study is about
This is a single center, randomly assigned, parallel assignment, and where neither patients nor doctors know which treatment is given compared against an inactive treatment 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 taken by mouth administered lyophilized PRIM-DJ2727 and the usual treatment (SOC) and the other 25 patients will be assigned to receive placebo and SOC for 4 weeks.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- 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.
Where
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 23, 2025 · Source of record for eligibility and locations