Poop pills from skinny donors: a new weapon against obesity?

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: \- 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 Inclusion criteria for RYGB-FMT intervention donors * 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 Inclusion criteria for LEAN-FMT intervention donors * Normal weight (BMI ≥ 20 to \< 25 \>18 years * Informed consent Exclusion Criteria: Exclusion criteria for patients • Non-Compliance * Insulin dependent diabetes mellitus, treated with GLP-1 agonists or poorly controlled on oral antidiabetic medications (HbA1C \> 8%) * Use of any weight loss medication or participation in a weight loss program * History of recent body weight change (defined as body weight loss or body weight gain of ≥ 5 kg within the two months preceding study enrolment). * Use of immunosuppressive medication or immune modulators (glucocorticoids, methotrexate, tacrolimus, cyclosporine, thalidomide, interleukin-10 or -11) within the last three months preceding study enrolment. * Congenital or acquired immunodeficiencies. * Anatomical reconstruction of the nutrient passage (i.e. hemicolectomy, resection of small bowel, gastrectomy, sleeve gastrectomy, gastric bypass surgery, biliopancreatic diversion, fundoplication etc) or cholecystectomy. * Chronic diarrhoea * History of serious chronic disease including malignancy, rheumatic heart disease, endocarditis, or valvular disease (due to risk of bacteremia) * Any condition, based on clinical judgment that may make study participation unsafe * Pregnancy or Breast Feeding Exclusion criteria for RYGB-FMT intervention donors * Intake of pre-, pro- or antibiotics within \< 3 months before study entry * Use of immunosuppressive medication or immune modulators (glucocorticoids, methotrexate, tacrolimus, cyclosporine, thalidomide, interleukin-10 or -11) within the last three months preceding study enrolment. * Congenital or acquired immunodeficiencies. * Chronic or acute infectious diseases (specified under 6.2.1) * Drug abuse * Anatomical reconstruction of the nutrient passage other than surgical RYGB configuration (i.e. hemicolectomy, resection of small bowel, fundoplication, LSG-to-RYGB transformation etc) or cholecystectomy. * History of recent body weight change (defined as body weight loss or body weight gain of ≥ 5 kg within the two months preceding study enrolment). * Chronic diarrhoea or steatorrhea or acute gastrointestinal infection within ≤ 3 months before study entry. * History of serious chronic disease including malignancy, chronic kidney disease (eGFR \< 60 ml/min), heart failure (NYHA ≥ III). * Any further condition, based on clinical judgment that may disqualify the candidate as an appropriate donor. Exclusion Criteria for Lean-FMT Intervention Donors • History of overweight or obesity in the past (BMI \> 25 kg/m2) • History of recent body weight change (defined as body weight loss or body weight gain of ≥ 5 kg within the two months preceding study enrolment). • HbA1C \> 6.5% or treatment with insulin or oral anti-diabetic medication. • Use of any weight loss medication or participation in a weight loss program • Use of immunosuppressive medication or immune modulators (glucocorticoids, methotrexate, tacrolimus, cyclosporine, thalidomide, interleukin-10 or -11) within the last three months preceding study enrolment. • Congenital or acquired immunodeficiencies. • Chronic or acute infectious diseases (specified under 6.2.1) • Drug abuse • Anatomical reconstruction of the nutrient passage (i.e. hemicolectomy, resection of small bowel, fundoplication etc) or cholecystectomy. • Chronic diarrhoea or acute gastrointestinal infection within ≤ 3 months before study entry. • History of serious chronic disease including malignancy, chronic kidney disease (eGFR \< 60 ml/min), heart failure (NYHA ≥ III). • Any further condition, based on clinical judgment that may disqualify the candidate as an appropriate donor.