Actively Recruiting
Metabolic Outcome of Obese Subjects Receiving Fecal Microbiota Transplantation of Lean Versus Gastric Bypass Treated Subjects. A Pilot Study
Led by Wiebke Kristin Fenske · Updated on 2025-03-30
30
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the effects of fecal microbiota transfer (FMT) in adults with morbid obesity who also have prediabetes or diabetes. The study compares FMT from three different donor sources: lean healthy donors, donors who have undergone successful Roux-en-Y gastric bypass (RYGB) surgery, and autologous FMT (using the patient’s own stool) as a control. The goal is to explore how changes in gut bacteria from these sources impact energy use, blood sugar regulation, and metabolic health in obese individuals. Participants will be randomly assigned to one of three groups receiving FMT treatments once a week for three weeks following antibiotic pretreatment. One group receives stool from donors who had RYGB surgery and achieved sustained weight loss and improved glucose control. Another group receives stool from lean, metabolically healthy donors, while the control group receives their own stool (autologous FMT). Donor samples are processed and stored under controlled conditions before transplantation. Throughout the study, participants will have stool samples collected and analyzed for microbiota and metabolite changes. Researchers will assess insulin sensitivity, glucose levels, body weight, blood pressure, lipid profiles, liver enzymes, dietary intake, inflammation, gut hormones, and quality of life over periods up to 24 weeks. Daily monitoring includes hunger and satiety scores and tolerability of repeated FMT. The study aims to determine the impact of different donor microbiota on obesity and metabolic health over time.
CONDITIONS
Brief 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 BMI of 40 kg/m2 or higher
- Prediabetes or diabetes with HbA1c of 5.7% or higher, or fasting plasma glucose over 5.6 mmol/l, or random plasma glucose over 11.1 mmol/l
- Informed consent to participate
- For RYGB-FMT donors: sustained weight loss of 30% or more for at least 12 months after gastric bypass surgery
- For RYGB-FMT donors: HbA1c less than 6.5% without insulin or oral antidiabetic drugs
- 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
- Donors must provide informed consent
You will not qualify if you...
- Non-compliance with study procedures
- Insulin-dependent diabetes, use of GLP-1 agonists, or poorly controlled diabetes (HbA1c over 8%)
- Use of weight loss medications or participation in weight loss programs
- Recent significant weight change of 5 kg or more in the last 2 months
- Use of immunosuppressive or immune-modulating medications within the last 3 months
- Congenital or acquired immune deficiencies
- Anatomical changes in digestive tract such as gastric bypass, gastrectomy, bowel resection, or gallbladder removal
- Chronic diarrhea
- Serious chronic diseases including cancer, rheumatic heart disease, endocarditis, or valvular disease
- Any condition that makes participation unsafe
- Pregnancy or breastfeeding
- For RYGB-FMT donors: recent antibiotic, prebiotic, or probiotic use within 3 months
- For RYGB-FMT donors: chronic or acute infections or drug abuse
- For RYGB-FMT donors: chronic kidney disease (eGFR less than 60 ml/min) or heart failure (NYHA class III or higher)
- For Lean-FMT donors: history of overweight or obesity
- For Lean-FMT donors: HbA1c over 6.5% or use of diabetic medications
- For Lean-FMT donors: chronic or acute infections or drug abuse
- For donors: any condition judged unsafe for donation based on clinical assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 weeks
Participants receive fecal microbiota transplantation (FMT) three times every 7 days following antibiotic pretreatment. Depending on group assignment, donor stool comes from patients treated with gastric bypass surgery, lean healthy donors, or autologous stool.
3 visits (in-person) weekly for FMT treatments
Duration - Up to 24 weeks after treatment
Participants are monitored for metabolic outcomes including insulin sensitivity, glucose homeostasis, body weight, blood pressure, lipid profiles, liver enzymes, dietary intake, metabolic inflammation, gut hormones, hunger and satiety scores, fecal microbiota composition, quality of life, and tolerability of repeated FMT.
Regular visits at 6, 16, and 24 weeks post-treatment
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.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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