RecruitingNot ApplicableNCT06268990

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


Sponsor

Wiebke Kristin Fenske

Enrollment

30 participants

Start Date

Jan 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This proof-of-concept study explores whether transplanting gut bacteria (fecal microbiota transplantation, or FMT) from either lean donors or formerly obese patients who had successful gastric bypass (RYGB) surgery can help obese adults lose weight and improve blood sugar control. Obese patients with a BMI of 40 or above and prediabetes or diabetes are randomized to one of three groups: receiving stool from a post-RYGB donor, from a lean healthy donor, or from themselves (placebo). Participation involves antibiotic pretreatment followed by three FMT sessions one week apart, with follow-up testing to measure changes in weight, blood sugar, and gut bacteria composition. Patients who have had prior stomach or bowel surgery, are on immunosuppressive medications, or have significant heart, kidney, or gastrointestinal conditions are not eligible. This summary was prepared as patient-facing educational content using AI assistance.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREFecal microbiota transplantation

FMT is the transfer of fecal material containing gut microorganisms from a donor into the intestinal tract of a recipient


Locations(1)

Department of Internal Medicine, Medical University Graz

Graz, Austria

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NCT06268990


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