FMT in Obesity: RYGB vs. LEAN vs. Autologous FMT

Korábbi kezelés

• 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.
• 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.
• 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.
• 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.
• Chronic diarrhoea or steatorrhea or acute gastrointestinal infection within ≤ 3 months before study entry.
• 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.
• 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.

Más betegség

• 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).
• 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
• Chronic or acute infectious diseases (specified under 6.2.1)
• 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).
• Any further condition, based on clinical judgment that may disqualify the candidate as an appropriate donor.
• 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 or acute infectious diseases (specified under 6.2.1)
• Any further condition, based on clinical judgment that may disqualify the candidate as an appropriate donor.

Laborértékek

• Insulin dependent diabetes mellitus, treated with GLP-1 agonists or poorly controlled on oral antidiabetic medications (HbA1C > 8%)
• History of serious chronic disease including malignancy, chronic kidney disease (eGFR < 60 ml/min), heart failure (NYHA ≥ III).
• HbA1C > 6.5% or treatment with insulin or oral anti-diabetic medication.
• History of serious chronic disease including malignancy, chronic kidney disease (eGFR < 60 ml/min), heart failure (NYHA ≥ III).

Egyéb

• Non-Compliance
• Congenital or acquired immunodeficiencies.
• Chronic diarrhoea
• Pregnancy or Breast Feeding
• Congenital or acquired immunodeficiencies.
• Congenital or acquired immunodeficiencies.

• 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