Metabolic Outcome of Obese Subjects Receiving Fecal Microbiota Transplantation of Lean Versus Gastric Bypass Treated Subjects. A Pilot Study
This double-blinded proof-of-concept study is proposed to explore the effects of fecal microbiota transfer (FMT) in human subjects. Here we perform FMTs into obese recipients using stool from lean unoperated donors and from previously obese patients after successfull treatment with bariatric Roux-en-Y Gastric Bypass (RYGB) surgery. Obese patients treated with their own material (autologous FMT) serve as controls. After FMT treatment the functional impact of post-surgery microbiome changes on host energy consumption and regulation of blood glucose levels will be analysed. Additionally the variations on the microbiota and metabolite composition will be profiled using extensive sequencing analyses. The major aim of the study is to explore the scientific rationale for targeted gut microbiota modulation in management of obesity and related metabolic diseases.We estimate the transfer of microbiota from RYGB donors is superior to the transfer of lean microbiota at inducing reduced adiposity and improving high blood glucose levels in obese recipients. Each is better than a sham procedure (autologous FMT), which itself can also induce considerable short-term effects.
⁃ \- Inclusion criteria for patients
• Age \>18 years
• Morbid obesity defined by a BMI ≥ 40 kg/m2
• Prediabetes or diabetes with HbA1C between ≥ 5.7 % OR
• Fasting plasma glucose \> 5.6 mmol/l (\> 100 mg/dl) (no caloric intake for at least 8 hours) OR
• Random plasma glucose \> 11.1 mmol/l (\> 200 mg/dl)
• Informed consent
• Sustained total weight loss of ≥30% ≥12 months after RYGB surgery
• HbA1c \< 6.5% without insulin treatment or oral antidiabetic medication
• Age \>18 years
• Informed consent
• Normal weight (BMI ≥ 20 to \< 25 \>18 years
• Informed consent