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

Not Applicable

• Conditions: Obesity (BMI >30 <40); type 2 diabetes mellitus (<24 months duration); Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN30359027
• Lead Sponsor: Abertawe Bro Morgannwg University Health Board

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-15
• Last Update Posted: 15 July 2019
• Study Completion: 2020-05-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 30

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

1. Abdominal tenderness on examination
2. BMI < 30 > 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 < 18 > 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified