Feasibility of faecal microbiota transplantation in the management of obesity and type 2 diabetes

Feasibility of faecal microbiota transplantation in the management of obesity and type 2 diabetes: a randomised feasibility study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN30359027

Enrollment

Registered

2018-11-15

Start date

2018-11-01

Completion date

Unknown

Last updated

2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity (BMI >30 <40)

Interventions

30 individuals randomised 1:1:1 (10 patients in each arm): 10 patients to receive personalised FMT (intervention group) + dietary advice 10 patients to receive autologo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged between 18-70 2. Ability to give informed consent 3. BMI > 30 but < 40 4. Confirmed T2DM (within 24 months) 5. Ability to undergo a full screening assessment 6. Willingness to receive FMT via the nasojejunal route 7. Negative pregnancy test (if applicable) 8. Women of childbearing potential agree to use highly effective contraception measures until trial ends

Exclusion criteria

Exclusion criteria: 1. Abdominal tenderness on examination 2. BMI 40 3. No evidence of T2DM or diagnosis of T2DM > 24 months 4. No clinical diagnosis of T1DM 5. Contraindication to receiving oral bowel preparation 6. Allergy to antibiotics used by the study 7. Age 70 8. Allergy to proton pump inhibitor 9. Patient classed from vulnerable group 10. Previous GI / bariatric surgery 11. Contraindication to naso-jejunal tube placement 12. Pregnant 13. Immuno-suppressed 14. Known communicable disease; at least two weeks post full recovery from infectious disease 15. Systemic autoimmunity or atopic disease 16. Previous prosthetic implant 17. Foreign travel to areas of enteric disease prevalence within three months 18. Malignancy 19. Mental health disorder (requiring therapy) 20. Chronic pain syndromes (e.g. fibromyalgia) 21. Recent transfusion, transplant or skin graft 22. Current/previous use of injected drugs or intranasal cocaine 23. High risk sexual behaviour (sexual contact with anyone with HIV / HTLV / AIDS or hepatitis B/C, men who have sex with men (MSM)) 24. Known exposure to HIV/hepatitis B/C 25. Tattooing, piercing, cosmetic botulinum (Botox) or permanent makeup within 120 days 26. Risk factors for variant Creutzfeldt-Jakob disease e.g blood transfusion or transplant after 1st January 1980 27. Neurologic, neuro-developmental or neurodegenerative disorders 28. Use of antibiotics for any indication within the past three months

Design outcomes

Primary

Measure	Time frame
Measured once the study is completed (i.e. all 30 patients have been recruited): 1. The feasibility of a future full trial of FMT in obesity and type 2 diabetes 2. The recruitment rate of donors and patients for a study of FMT 3. The choice of endpoints for a future phase III trial 4. The number of patients required at phase III to demonstrate efficacy of FMT in the treatment of obesity and type 2 diabetes	—

Measure

Time frame

Measured once the study is completed (i.e. all 30 patients have been recruited): 1. The feasibility of a future full trial of FMT in obesity and type 2 diabetes 2. The recruitment rate of donors and patients for a study of FMT 3. The choice of endpoints for a future phase III trial 4. The number of patients required at phase III to demonstrate efficacy of FMT in the treatment of obesity and type 2 diabetes

—

Secondary

Measure	Time frame
The magnitude of treatment response to FMT in obesity and T2DM, measured using BMI, anthropometric measurements, blood tests and patient reported outcome measures at baseline and 12 weeks post intervention	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026