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

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ClinicalTrials.gov Identifier: NCT06024681
Recruitment Status : Completed
First Posted : September 6, 2023
Last Update Posted : March 6, 2024
Sponsor:
Collaborator:
King's College London
Information provided by (Responsible Party):
Imperial College London

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Non-Alcoholic Fatty Liver Disease Fecal Microbiota Transplantation Other: Faecal microbiota transplant Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Human participants with NAFLD and fibrosis
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Investigating the Impact of Faecal Microbiota Transplant on the Clinical Phenome of Patients With Non-alcoholic Fatty Liver Disease and Fibrosis
Actual Study Start Date : July 20, 2021
Actual Primary Completion Date : September 29, 2023
Actual Study Completion Date : October 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: NAFLD patients
Patients receiving capsulised FMT
 Other: Faecal microbiota transplant
Capsulised faecal microbiota transplant prepared from rationally selected donor, based upon donor metabolomic charateristics


Outcome Measures
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Primary Outcome Measures :
  1. Change in faecal microbiome composition [ Time Frame: 24 weeks after initial FMT ]
    Using 16S rRNA gene sequencing and shotgun metagenomic sequencing

  2. Change in gut microbial metabolite composition [ Time Frame: 24 weeks after initial FMT ]
    Using 1H-NMR and mass spectrometry


Secondary Outcome Measures :
  1. Changes in liver fat on MRI [ Time Frame: 16 weeks after initial FMT ]
    Using MRI-PDFF

  2. Changes in liver fat on FibroScan [ Time Frame: 16 weeks after initial FMT ]
    Using CAP

  3. Changes in liver stiffness on MRI [ Time Frame: 16 weeks after initial FMT ]
    Using MRE

  4. Changes in liver stiffness on FibroScan [ Time Frame: 16 weeks after initial FMT ]
    Using transient elastography

  5. Changes in HbA1c [ Time Frame: 24 weeks after initial FMT ]
  6. Changes in insulin resistance [ Time Frame: 24 weeks after initial FMT ]
    Combining fasting glucose and insulin levels to generate HOMA-IR

  7. Changes in BMI [ Time Frame: 24 weeks after initial FMT ]
    Through combination of measurement of weight in kilogram and height in metres, reporting BMI in kg/m^2

  8. Changes in lipid metabolism [ Time Frame: 24 weeks after initial FMT ]
    Serum lipid profile


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18-75 years of age.
  2. Previously-diagnosed NAFLD, with predicted fibrosis based upon non-invasive assessment with FibroScan (i.e. liver stiffness measurement (LSM) > 8kPa).
  3. 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).
  4. Able to consent for themselves in English.

Exclusion Criteria:

  1. Severe or life-threatening food allergy.
  2. Pregnant or lactating women; or women trying to conceive.
  3. Patients with suspected or confirmed cirrhosis (as assessed by clinical, radiological or histological criteria).

  4. Use of particular medications, including:

    1. Systemic antibiotics within the six weeks prior to study enrolment.
    2. 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).
    3. Use of GLP-1 agonists.
  5. Patients not expected to survive the duration of the study's follow-up (six months).
  6. Swallowing difficulties that may preclude safe use of FMT capsules, including oral-motor dyscoordination.
  7. Alcohol consumption > 20g/ day.
  8. Any active cancer (including treatment within the past six months).
  9. Active infection at the point of recruitment, including COVID-19 infection.
  10. Prior receipt of a liver transplant.
  11. BMI < 23 in Asian potential participants and BMI < 25 in Caucasians.
  12. Advanced chronic kidney disease (eGFR < 30 ml/min).
  13. Chronic intestinal disease, including coeliac disease, cystic fibrosis, inflammatory bowel disease, irritable bowel syndrome, and chronic diarrhoea.
  14. Prior bariatric surgery.
  15. Patients unable to undergo MRI scans (e.g. due to the individual having metallic implants).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06024681


Locations
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United Kingdom
Division of Digestive Diseases/ Liver Unit, St Mary's Hospital Campus, Imperial College London
London, United Kingdom, W2 1NY
Sponsors and Collaborators
Imperial College London
King's College London
Investigators
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Principal Investigator: Pinelopi Manousou, MD PhD Imperial College London
More Information
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT06024681    
Other Study ID Numbers: ICL_21SM6787
296522 ( Other Identifier: IRAS )
21/LO/0454 ( Other Identifier: REC )
First Posted: September 6, 2023    Key Record Dates
Last Update Posted: March 6, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only anonymised microbiome and metabolome data will be shared with other researchers via open access repositories

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
NAFLD
Gut microbiome
Metabolomics
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases