NCT06024681

Impact of FMT on the Phenome in Patients With NAFLD and Fibrosis

Investigating the Impact of Faecal Microbiota Transplant on the Clinical Phenome of Patients With Non-alcoholic Fatty Liver Disease and Fibrosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this pilot experimental medicine interventional study is to explore the degree of transferability of the gut microbiome and associated metabolomic changes in patients with non-alcoholic fatty liver disease (NAFLD) and fibrosis who receive faecal microbiota transplant (FMT). The main questions is aims to answer is: * To what extent is the gut microbiome transferable from donor to recipient in patients with NAFLD with fibrosis who receive FMT? * What are the dynamics of how the gut microbiome changes over time in these patients? * To what degree does the recipient metabolome change in association with this? Participants will receive up to three capsulised FMT preparations prepared from a donor selected rationally based upon their metabolomic characteristics. They will be asked to attend for serial clinical assessments (including FibroScan and MRE/ MRI-PDFF), and will also be asked to provide serial blood, urine and stool samples for assessment of microbiome and metabolome profiling.

Conditions

• Non-Alcoholic Fatty Liver Disease
• Fecal Microbiota Transplantation

Interventions

Type	Name	Description
OTHER	Faecal microbiota transplant	Capsulised faecal microbiota transplant prepared from rationally selected donor, based upon donor metabolomic charateristics

Timeline

• Start date: 2021-07-20
• Primary completion: 2023-09-29
• Completion: 2023-10-31
• First posted: 2023-09-06
• Last updated: 2024-03-06

Locations

1 site across 1 country: United Kingdom