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

NCT06024681 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-03-06

No results posted yet for this study

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

OTHER

Faecal microbiota transplant

Capsulised faecal microbiota transplant prepared from rationally selected donor, based upon donor metabolomic charateristics

Sponsors & Collaborators

Principal Investigators

  • Pinelopi Manousou, MD PhD · Imperial College London

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-20
Primary Completion
2023-09-29
Completion
2023-10-31

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06024681 on ClinicalTrials.gov