A prospective, randomized placebo controlled feasibility trial of faecal microbiota transplantation in cirrhosis.

Phase 1

• Conditions: Cirrhosis of the liver; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]; MedDRA version: 20.0Level: LLTClassification code 10024667Term: Liver cirrhosisSystem Organ Class: 100000004871

• Registration Number: EUCTR2017-003629-13-GB
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-05
• Last Update Posted: 25 May 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• 18–75 years
• Confirmed advanced cirrhosis of any aetiology with a MELD score between 10 and 16. The diagnosis of liver cirrhosis will be based on clinical, radiological, or histological criteria.
• Patients with alcohol-related liver disease must have been abstinent from alcohol for a minimum of 6 weeks.
• Patients must be deemed to have capacity to consent to study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 32
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32

Exclusion Criteria

• Severe or life-threatening food allergy
• Pregnancy or breastfeeding
• Patients treated for active variceal bleeding, infection, bacterial peritonitis, overt hepatic encephalopathy or acute-on-chronic liver failure within the past 14 days.
• Patients who have received antibiotics in the past 14 days.
• Active alcohol consumption of >20 grams/day.
• Has had a previous liver transplant
• Hepatocellular carcinoma outside of the Milan Criteria (2)
• A history of prior gastrointestinal resection such as gastric bypass
• Patient is not expected to survive the duration of the study (90 days).
• Severe renal impairment (creatinine >150 µmol/L)
• Inflammatory bowel disease (IBD)
• Coeliac disease
• HIV positive
• Immunosuppression e.g. more than two weeks treatment with corticosteroids within 8 weeks of intervention, active treatment with tacrolimus, mycophenylate, azathioprine

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified