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NCT04577729
The IRMI-FMT Trial
NA trial testing Allogenic Fecal Microbiota Transplantation in Fecal Microbiota Transplantation in 5 participants. Terminated before completion.
7 June 2023
Quick facts
| Lead sponsor | Medical University of Graz |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 5 |
| Start date | 21 May 2021 |
| Primary completion | 7 June 2023 |
| Estimated completion | 7 June 2023 |
| Sites | 1 location across Austria |
Drugs / interventions tested
- Allogenic Fecal Microbiota Transplantation
- Autologous Fecal Microbiota Transplantation — full drug profile →
Conditions studied
- Fecal Microbiota Transplantation — all drugs for Fecal Microbiota Transplantation →
- Malignant Melanoma Stage III — all drugs for Malignant Melanoma Stage III →
- Malignant Melanoma Stage IV — all drugs for Malignant Melanoma Stage IV →
Sponsor
Medical University of Graz
Who can join
18 and older, any sex, with Fecal Microbiota Transplantation or Malignant Melanoma Stage III. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Aim of the study is to investigate the effect of Fecal Microbiota Transplantation (FMT) and Checkpoint Inhibitor (CI) re-challenge in prior CI refractory patients on Progression free survival (PFS) and tumor using donor stool of former malignant melanoma patients, who have been in remission due to CI treatment for at least 1 year.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Gut microbiota influence immunotherapy responses: mechanisms and therapeutic strategies.
Lu Y, Yuan X, Wang M, He Z, et al · · 2022 · cited 360× · PMID 35488243 · DOI 10.1186/s13045-022-01273-9 -
Cancer and the Microbiome-Influence of the Commensal Microbiota on Cancer, Immune Responses, and Immunotherapy.
Matson V, Chervin CS, Gajewski TF. · · 2021 · cited 286× · PMID 33253684 · DOI 10.1053/j.gastro.2020.11.041 -
Gut OncoMicrobiome Signatures (GOMS) as next-generation biomarkers for cancer immunotherapy.
Thomas AM, Fidelle M, Routy B, Kroemer G, et al · · 2023 · cited 100× · PMID 37365438 · DOI 10.1038/s41571-023-00785-8 -
Modulating gut microbiome in cancer immunotherapy: Harnessing microbes to enhance treatment efficacy.
Kang X, Lau HC, Yu J. · · 2024 · cited 65× · PMID 38631285 · DOI 10.1016/j.xcrm.2024.101478 -
Antitumor effects of fecal microbiota transplantation: Implications for microbiome modulation in cancer treatment.
Xu H, Cao C, Ren Y, Weng S, et al · · 2022 · cited 63× · PMID 36177041 · DOI 10.3389/fimmu.2022.949490 -
The future of affordable cancer immunotherapy.
Schaft N, Dörrie J, Schuler G, Schuler-Thurner B, et al · · 2023 · cited 50× · PMID 37736099 · DOI 10.3389/fimmu.2023.1248867 -
From chaos to order: optimizing fecal microbiota transplantation for enhanced immune checkpoint inhibitors efficacy.
Lin A, Jiang A, Huang L, Li Y, et al · · 2025 · cited 45× · PMID 39826104 · DOI 10.1080/19490976.2025.2452277 -
Fecal microbiota transplantation: no longer cinderella in tumour immunotherapy.
Yang Y, An Y, Dong Y, Chu Q, et al · · 2024 · cited 43× · PMID 38241975 · DOI 10.1016/j.ebiom.2024.104967
Verify or expand the search:
- PubMed search for NCT04577729
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Fecal Microbiota Transplantation
Currently open trials in the same condition.
- NCT06282952 — Health Outcomes in C-Section Infants With Fecal Microbiota Transplantation · NA · recruiting
- NCT07149441 — Efficacy and Mechanism of FMT in the Treatment of Inflammatory Bowel Disease: an Open-label Randomized Controlled Study · NA · active not recruiting
- NCT06920212 — Clinical Safety and Efficacy of Fecal Microbiota Transplantation (FMT) in the Treatment of Alzheimer's Disease · NA · active not recruiting
- NCT05790356 — Fecal Microbial Transplantation for Rheumatoid Arthritis Trial · NA · recruiting
- NCT06782880 — Fecal Microbiota Transplantation for the Prevention of Infectious Complications After Liver Transplantation · NA · recruiting
Other Medical University of Graz trials
Trials by the same sponsor.
- NCT07498244 — Collagen Fingerprinting for Stratification of Pulmonary Hypertension (PH) Patients · recruiting
- NCT07492823 — Clinical Applicability of Liquid Biopsy in Chondrosarcoma · not yet recruiting
- NCT07297615 — 3D Liver Volumetry · NA · not yet recruiting
- NCT07588282 — The Effect of Psychoeducational Diagnosis Communication on Perception of Illness, Satisfaction, and Behavioral Intention · NA · recruiting
- NCT07376096 — Liquid Biopsy in Germ Cell Tumors · not yet recruiting
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 NCT04577729 (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 Medical University of Graz
- Last refreshed: 10 July 2023
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/NCT04577729.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing