None listed
Conditions
Brief summary
An assessment of the role of FMT in the treatment of obesity and type 2 diabetes. Eligible participants will be randomised to either the intervention group or the control group. Regardless of allocation group, each participant will receive best practise exercise and weight loss dietary advice (high vegetable intake to maintain healthy microbiome) provided verbally and in writing. Each participant will then undergo a colonoscopy and take an inulin-type fructans supplement orally twice daily for the study duration. The intervention group will receive a faecal transplant from a specimen provided by a healthy donor. The control group will receive an autologous faecal transplant.
Interventions
Eligible participants will be randomised to either the intervention group or the control group. The study population will comprise 80 adults randomised to receive either donor FMT via colonoscopy (40 people) or receive autologous (their own) faecal material (40 people). The intervention group (only 40 people) will receive a faecal transplant from a specimen provided by a healthy donor.
The FMT is done via colonoscopy following homogenisation with 500 ml of normal saline and filtering of any res
Eligible participants will be randomised to either the intervention group or the control group. The study population will comprise 80 adults randomised to receive either donor FMT via colonoscopy (40 people) or receive autologous (their own) faecal material (40 people). The intervention group (only 40 people) will receive a faecal transplant from a specimen provided by a healthy donor. The FMT is done via colonoscopy following homogenisation with 500 ml of normal saline and filtering of any residual solid material via a sterile kitchen strainer. 100-200 g of faecal material is used (dependent on specimen size provided). The colonoscopy for the FMT takes between 5 and 10 minutes to perform and is preformed by one 3 Gastroenterologists involved in the study (Dr Stephen Fairley, Dr Gillian Mahy or Dr Crispin Musumba). Monitoring of adherence to protocol is done by 2 other medical practitioners, not involved in the study. (Dr Martin McGahan and Dr Alan Nelson). They will be present for 25% pf the FMT procedures performed. The participants will be followed up by our research nurse on every three month for a twelve month period. The participants will be encouraged to meeting with the research nurse of any adverse outcomes or concerns should these occur between the formal three monthly reviews.
Sponsors
Dr Stephen Fairley
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Aged 18-65 years, able to understand the plain language summary and competent to make informed consent. Obese (BMI >= 30), features of MetS (central obesity plus at least one of diabetes, HbA1c >6.5% or 48 mmol/mol, hypertension (BP>140/90), dyslipidemia (TG>1.5 mmol/L and/or HDL-Cholesterol <1.0 mmol/l).
Exclusion criteria
People having, a) major mental or other illnesses which would preclude consent or affect clinical risk (e.g. cancer diagnosis, known gut polyps). b) currently taking medication which would affect gut flora (e.g. antibiotics). c) Pregnant women
Outcome results
None listed