Actively Recruiting
FMT in Obesity: RYGB vs. LEAN vs. Autologous FMT
Led by Wiebke Kristin Fenske · Updated on 2025-03-30
30
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
W
Wiebke Kristin Fenske
Lead Sponsor
M
Medical University of Graz
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
FMT in Obesity: RYGB vs. LEAN vs. Autologous FMT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Morbid obesity with a BMI of 40 kg/m2 or higher
- Prediabetes or diabetes with HbA1C 5.7% or higher OR fasting plasma glucose over 5.6 mmol/l (100 mg/dl) after fasting at least 8 hours OR random plasma glucose over 11.1 mmol/l (200 mg/dl)
- Informed consent
- For RYGB-FMT donors: sustained total weight loss of 30% or more for at least 12 months after RYGB surgery
- For RYGB-FMT donors: HbA1c less than 6.5% without insulin or oral antidiabetic medication
- For RYGB-FMT donors: age over 18 years
- For LEAN-FMT donors: normal weight with BMI between 20 and less than 25
- For LEAN-FMT donors: age over 18 years
- For all donors: informed consent
You will not qualify if you...
- Non-compliance
- Insulin-dependent diabetes treated with GLP-1 agonists or poorly controlled oral medication (HbA1C over 8%)
- Use of weight loss medication or participation in a weight loss program
- Recent body weight change of 5 kg or more within the last two months
- Use of immunosuppressive medication or immune modulators within the last three months
- Congenital or acquired immunodeficiencies
- Anatomical reconstruction of nutrient passage or cholecystectomy
- Chronic diarrhea
- History of serious chronic diseases including malignancy, rheumatic heart disease, endocarditis, or valvular disease
- Any condition that may make participation unsafe
- Pregnancy or breastfeeding
- For RYGB-FMT donors: recent intake of pre-, pro-, or antibiotics within 3 months
- For RYGB-FMT donors: chronic or acute infectious diseases, drug abuse, recent gastrointestinal infections, chronic kidney disease (eGFR < 60 ml/min), heart failure NYHA class III or higher
- For LEAN-FMT donors: history of overweight or obesity (BMI over 25), HbA1C over 6.5% or treatment with insulin or oral anti-diabetic medication
- For LEAN-FMT donors: recent body weight change of 5 kg or more within two months
- For LEAN-FMT donors: chronic or acute infectious diseases, drug abuse, recent gastrointestinal infections, chronic kidney disease (eGFR < 60 ml/min), heart failure NYHA class III or higher
- Any other condition that may disqualify the candidate as judged clinically
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Internal Medicine, Medical University Graz
Graz, Austria, 8010
Actively Recruiting
Research Team
W
Wiebke K. Fenske, Prof. Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here