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NCT06268990: DACH
FMT in Obesity: RYGB vs. LEAN vs. Autologous FMT
NA trial testing Fecal microbiota transplantation in Morbid Obesity in 30 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | Wiebke Kristin Fenske |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 January 2023 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across Austria |
Drugs / interventions tested
- Fecal microbiota transplantation — full drug profile →
Conditions studied
- Morbid Obesity — all drugs for Morbid Obesity →
- Metabolic Syndrome — all drugs for Metabolic Syndrome →
- Diabetes — all drugs for Diabetes →
- PreDiabetes — all drugs for PreDiabetes →
Sponsor
Wiebke Kristin Fenske
Who can join
Adults 18 to 60, any sex, with Morbid Obesity or Metabolic Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Unraveling the gut microbiota's role in obesity: key metabolites, microbial species, and therapeutic insights.
Iqbal M, Yu Q, Tang J, Xiang J. · · 2025 · cited 15× · PMID 40183584 · DOI 10.1128/jb.00479-24
Verify or expand the search:
- PubMed search for NCT06268990
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Fecal microbiota transplantation
Trials testing the same drug.
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- NCT06478602 — Implications of Fecal Microbiota Transplantation in Modulating the Effects of Liver Cirrhosis · Phase 3 · completed
- NCT06290258 — Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder. · Phase 1, PHASE2 · recruiting
- NCT05873348 — A Controlled Study on Regulation of Systemic Inflammation by Fecal Bacteria Transplantation in Patients With COVID-19. · NA · completed
- NCT06591013 — Efficacy and Mechanism of Fecal Microbiota Transplantation of the Bai Ethnicity in the Treatment of UC · NA · completed
Other recruiting trials for Morbid Obesity
Currently open trials in the same condition.
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- NCT07289555 — Tailored Stapled SADI-S: Initial Report and Preliminary Results · NA · recruiting
- NCT07263269 — Comparing Dumping Symptoms and Quality of Life 6 Months After Sleeve Gastrectomy With or Without Transit Bipartition in · NA · active not recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06268990 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Wiebke Kristin Fenske
- Last refreshed: 30 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06268990.
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