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NCT06268990Completed

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

Metabolic Outcome of Obese Subjects Receiving Fecal Microbiota Transplantation of Lean Versus Gastric Bypass Treated Subjects. A Pilot Study

Source: ClinicalTrials.gov · Last updated 26 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
29 (actual)
First submitted
29 Jan 2024
Start date
1 Jan 2023
Primary completion date
6 Nov 2025
Lead sponsor
Wiebke Kristin Fenske
Diseases
Obesity
NCT number
NCT06268990

What you commit to

  • Study type: Interventional
  • Participants enrolled: 29
  • From 1 Jan 2023 to the primary completion date, 6 Nov 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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.

Lab values

  • 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).

Other

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

Who the study is looking for

  • \- 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

Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Department of Internal Medicine, Medical University Graz
Coordinator of this site? Confirm its status
GrazAustriaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.