Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 296522 | Other Identifier | IRAS | |
| 21/LO/0454 | Other Identifier | REC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| King's College London | OTHER |
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NAFLD patients | Experimental | Patients receiving capsulised FMT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Faecal microbiota transplant | Other | Capsulised faecal microbiota transplant prepared from rationally selected donor, based upon donor metabolomic charateristics |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in faecal microbiome composition | Using 16S rRNA gene sequencing and shotgun metagenomic sequencing | 24 weeks after initial FMT |
| Change in gut microbial metabolite composition | Using 1H-NMR and mass spectrometry | 24 weeks after initial FMT |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in liver fat on MRI | Using MRI-PDFF | 16 weeks after initial FMT |
| Changes in liver fat on FibroScan | Using CAP | 16 weeks after initial FMT |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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).
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pinelopi Manousou, MD PhD | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Digestive Diseases/ Liver Unit, St Mary's Hospital Campus, Imperial College London | London | W2 1NY | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40568349 | Derived | 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. |
Not provided
Not provided
Only anonymised microbiome and metabolome data will be shared with other researchers via open access repositories
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Human participants with NAFLD and fibrosis
Not provided
Not provided
Not provided
Not provided
| Changes in liver stiffness on MRI | Using MRE | 16 weeks after initial FMT |
| Changes in liver stiffness on FibroScan | Using transient elastography | 16 weeks after initial FMT |
| Changes in HbA1c | 24 weeks after initial FMT |
| Changes in insulin resistance | Combining fasting glucose and insulin levels to generate HOMA-IR | 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 | 24 weeks after initial FMT |
| Changes in lipid metabolism | Serum lipid profile | 24 weeks after initial FMT |