Safety Evaluation of Fecal Microbiota Transplantation in Severe Alcoholic Hepatitis
Alcoholic Hepatitis
About this trial
This is an interventional other trial for Alcoholic Hepatitis focused on measuring Severe alcoholic hepatitis
Eligibility Criteria
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.
Sites / Locations
- Baylor St. Luke Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Intervention Arm
Placebo 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.
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.