Safety Evaluation of Fecal Microbiota Transplantation in Severe Alcoholic Hepatitis

Launched by PRASUN KUMAR JALAL · Aug 12, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the safety of a treatment called fecal microbiota transplantation (FMT) for people with severe alcoholic hepatitis, a serious liver condition caused by heavy drinking. Researchers are trying to understand how this treatment affects the gut bacteria of patients and if it can improve their health. The study will involve 50 participants who are randomly divided into two groups: one group will receive the FMT capsules along with standard medical care, while the other group will receive a placebo (an inactive treatment) with the same standard care for four weeks.

To participate in this trial, individuals need to be between 18 and 75 years old and have been diagnosed with severe alcoholic hepatitis. This includes having symptoms like jaundice (yellowing of the skin) and meeting specific health criteria related to liver function. Participants can expect to take the capsules for four weeks and receive regular medical care throughout the study. It’s important to note that certain health issues, such as other liver diseases or infections, may exclude someone from joining the trial to ensure their safety.

Gender

ALL

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.