Non-Alcoholic Fatty Liver DiseaseNCT06024681
Impact of FMT on the Phenome in Patients With NAFLD and Fibrosis
A study testing Faecal microbiota transplant in people with Non-Alcoholic Fatty Liver Disease and Fecal Microbiota Transplantation, run by Imperial College London at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Fecal Microbiota Transplantation
- What is being tested?
- Faecal microbiota transplant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jul 2021to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years of age.
- Previously-diagnosed NAFLD, with predicted fibrosis based upon non-invasive assessment with FibroScan (i.e. liver stiffness measurement (LSM) > 8kPa).
- Raised liver ALT (> 30IU/l for men, > 19IU/l for women) or AST (> 37IU/l for men, > 31IU/l for women) with negative non-invasive liver screen (including negative screen for viral hepatitis, autoimmune liver disease and metabolic liver disease, and normal echocardiogram within two years in the scenario where congestive hepatopathy may be considered).
- Able to consent for themselves in English.
Who cannot join
- Severe or life-threatening food allergy.
- Pregnant or lactating women; or women trying to conceive.
- Patients with suspected or confirmed cirrhosis (as assessed by clinical, radiological or histological criteria).
- Use of particular medications, including:
- Systemic antibiotics within the six weeks prior to study enrolment.
- Immunosuppression that may influence risks related to FMT (including - but not limited to: use of corticosteroids within eight weeks of intervention; use of cytotoxic chemotherapy; use of azathioprine, tacrolimus, mycophenolate mofetil and/or immunosuppressive biologic therapy, e.g. infliximab).
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- Use of GLP-1 agonists.
- Patients not expected to survive the duration of the study's follow-up (six months).
- Swallowing difficulties that may preclude safe use of FMT capsules, including oral-motor dyscoordination.
- Alcohol consumption > 20g/ day.
- Any active cancer (including treatment within the past six months).
- Active infection at the point of recruitment, including COVID-19 infection.
- Prior receipt of a liver transplant.
- BMI < 23 in Asian potential participants and BMI < 25 in Caucasians.
- Advanced chronic kidney disease (eGFR < 30 ml/min).
- Chronic intestinal disease, including coeliac disease, cystic fibrosis, inflammatory bowel disease, irritable bowel syndrome, and chronic diarrhoea.
- Prior bariatric surgery.
- Patients unable to undergo MRI scans (e.g. due to the individual having metallic implants).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Division of Digestive Diseases/ Liver Unit, St Mary's Hospital Campus, Imperial College London
London, W2 1NY
About this study
Official title: Investigating the Impact of Faecal Microbiota Transplant on the Clinical Phenome of Patients With Non-alcoholic Fatty Liver Disease and Fibrosis
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.
- Being tested
- Faecal microbiota transplant
- Keywords
- NAFLD, Gut microbiome, Metabolomics
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faecal microbiota transplantOther
Capsulised faecal microbiota transplant prepared from rationally selected donor, based upon donor metabolomic charateristics
| Study group | Role | What they receive |
|---|---|---|
| NAFLD patients | Experimental | Patients receiving capsulised FMT Receives: Other: Faecal microbiota transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in faecal microbiome composition
Using 16S rRNA gene sequencing and shotgun metagenomic sequencing
Measured: 24 weeks after initial FMT
Change in gut microbial metabolite composition
Using 1H-NMR and mass spectrometry
Measured: 24 weeks after initial FMT
Secondary outcomes (8)
Changes in liver fat on MRI
Using MRI-PDFF
Measured: 16 weeks after initial FMT
Changes in liver fat on FibroScan
Using CAP
Measured: 16 weeks after initial FMT
Changes in liver stiffness on MRI
Using MRE
Measured: 16 weeks after initial FMT
Changes in liver stiffness on FibroScan
Using transient elastography
Measured: 16 weeks after initial FMT
Changes in HbA1c
Measured: 24 weeks after initial FMT
Changes in insulin resistance
Combining fasting glucose and insulin levels to generate HOMA-IR
Measured: 24 weeks after initial FMT
Changes in BMI
Through combination of measurement of weight in kilogram and height in metres, reporting BMI in kg/m^2
Measured: 24 weeks after initial FMT
Changes in lipid metabolism
Serum lipid profile
Measured: 24 weeks after initial FMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start20 Jul 2021
- Primary completion29 Sep 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Human participants with NAFLD and fibrosis
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Pinelopi Manousou, MD PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024681
- Sponsor's protocol ID
- ICL_21SM6787
- Other IDs
- 296522, 21/LO/0454
- Status last verified
- Mar 2024
- First submitted
- 23 Aug 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only anonymised microbiome and metabolome data will be shared with other researchers via open access repositories
Publications
Aghara H, Patel M, Chadha P, Parwani K, Chaturvedi R, Mandal P. Unraveling the Gut-Liver-Brain Axis: Microbiome, Inflammation, and Emerging Therapeutic Approaches. Mediators Inflamm. 2025 Jun 18;2025:6733477. doi: 10.1155/mi/6733477. eCollection 2025.
PubMed 40568349
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of Faecal Microbiota Transplant on the Clinical Phenome of Patients With Non-alcoholic Fatty Liver Disease and Fibrosis
- ClinicalTrials.gov ID
- NCT06024681
- Acronym / sponsor ID
- ICL_21SM6787
- Keywords
- NAFLD, Gut microbiome, Metabolomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Human participants with NAFLD and fibrosis
| Arm | Type | Receives |
|---|---|---|
| NAFLD patients | Experimental | Other: Faecal microbiota transplantPatients receiving capsulised FMT |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-75 years of age.
- Previously-diagnosed NAFLD, with predicted fibrosis based upon non-invasive assessment with FibroScan (i.e. liver stiffness measurement (LSM) > 8kPa).
- Raised liver ALT (> 30IU/l for men, > 19IU/l for women) or AST (> 37IU/l for men, > 31IU/l for women) with negative non-invasive liver screen (including negative screen for viral hepatitis, autoimmune liver disease and metabolic liver disease, and normal echocardiogram within two years in the scenario where congestive hepatopathy may be considered).
- Able to consent for themselves in English.
Key exclusion criteria (18 listed)
- Severe or life-threatening food allergy.
- Pregnant or lactating women; or women trying to conceive.
- Patients with suspected or confirmed cirrhosis (as assessed by clinical, radiological or histological criteria).
- Use of particular medications, including:
- Patients not expected to survive the duration of the study's follow-up (six months).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Faecal microbiota transplantCapsulised faecal microbiota transplant prepared from rationally selected donor, based upon donor metabolomic charateristics | Other | NAFLD patients |
Primary outcome
Change in faecal microbiome composition
Time frame: 24 weeks after initial FMT
Using 16S rRNA gene sequencing and shotgun metagenomic sequencing
Change in gut microbial metabolite composition
Time frame: 24 weeks after initial FMT
Using 1H-NMR and mass spectrometry
8 secondary outcomes
Changes in liver fat on MRI
Time frame: 16 weeks after initial FMT
Changes in liver fat on FibroScan
Time frame: 16 weeks after initial FMT
Changes in liver stiffness on MRI
Time frame: 16 weeks after initial FMT
Changes in liver stiffness on FibroScan
Time frame: 16 weeks after initial FMT
Changes in HbA1c
Time frame: 24 weeks after initial FMT
Changes in insulin resistance
Time frame: 24 weeks after initial FMT
Changes in BMI
Time frame: 24 weeks after initial FMT
Changes in lipid metabolism
Time frame: 24 weeks after initial FMT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Derived from this study: PubMed 40568349Aghara H, Patel M, Chadha P, Parwani K, Chaturvedi R, Mandal P. Unraveling the Gut-Liver-Brain Axis: Microbiome, Inflammation, and Emerging Therapeutic Approaches. Mediators Inflamm. 2025 Jun 18;2025:6733477. doi: 10.1155/mi/6733477. eCollection 2025.
- Individual participant dataSharing planned: No. Only anonymised microbiome and metabolome data will be shared with other researchers via open access repositories
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pinelopi Manousou, MD PhD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Faecal microbiota transplant in people with Non-Alcoholic Fatty Liver Disease and Fecal Microbiota Transplantation, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in faecal microbiome composition (time frame: 24 weeks after initial FMT). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06024681, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.