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NCT03561532: FMT-CU
Fecal Transplantation in Ulcerative Colitis
NA trial testing Fecal microbiota transplantation (FMT) in Ulcerative Colitis in 48 participants. Status unknown.
31 May 2020
Quick facts
| Lead sponsor | Joint Authority for Päijät-Häme Social and Health Care |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 48 |
| Start date | 1 October 2016 |
| Primary completion | 31 May 2020 |
| Estimated completion | 31 May 2020 |
| Sites | 2 locations across Finland |
Drugs / interventions tested
- Fecal microbiota transplantation (FMT) — full drug profile →
- Placebo
Conditions studied
- Ulcerative Colitis — all drugs for Ulcerative Colitis →
Sponsor
Joint Authority for Päijät-Häme Social and Health Care — full company profile →
Who can join
Adults 18 to 75, any sex, with Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Adult individuals with ulcerative colitis in remission are given a single fecal microbiota transplantation (FMT) in colonoscopy. A half of the patients will receive autologous FMT as a placebo and a half will receive an FMT from a healthy donor.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Microbial-Based and Microbial-Targeted Therapies for Inflammatory Bowel Diseases.
Oka A, Sartor RB. · · 2020 · cited 126× · PMID 32006212 · DOI 10.1007/s10620-020-06090-z -
Fecal microbiota transplantation beyond Clostridioides difficile infections.
Wortelboer K, Nieuwdorp M, Herrema H. · · 2019 · cited 111× · PMID 31201141 · DOI 10.1016/j.ebiom.2019.05.066 -
Fecal transplantation for treatment of inflammatory bowel disease.
Imdad A, Pandit NG, Zaman M, Minkoff NZ, et al · · 2023 · cited 51× · PMID 37094824 · DOI 10.1002/14651858.cd012774.pub3 -
Fecal microbiota transplantation for the maintenance of remission in patients with ulcerative colitis: A randomized controlled trial.
Lahtinen P, Jalanka J, Mattila E, Tillonen J, et al · · 2023 · cited 32× · PMID 37213403 · DOI 10.3748/wjg.v29.i17.2666 -
Ulcerative Colitis: Advances in Pathogenesis, Biomarkers, and Therapeutic Strategies.
Bu S, Cheng X, Chen M, Yu Y. · · 2025 · cited 1× · PMID 40937422 · DOI 10.2147/pgpm.s536459 -
Effectiveness and safety of non-pharmacological therapies for the treatment of inflammatory bowel disease: a network meta-analysis.
Jia J, Wu YB, Liu SW, Chen WJ, et al · · 2025 · PMID 40662074 · DOI 10.3389/fmed.2025.1593483
Verify or expand the search:
- PubMed search for NCT03561532
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Fecal microbiota transplantation (FMT)
Trials testing the same drug.
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- NCT07276100 — Fecal Microbiota Transplantation to RESCUE Patients With Unresectable Hcc Progressors to First Line Therapy With Atezoli · Phase 2 · recruiting
- NCT07319364 — A Real-World Study of Fecal Transplants for Cancer Therapy Side Effects · Phase 1 · recruiting
- NCT07003438 — Study on the Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Steroid - Dependent /Steroid-re · EARLY_PHASE1 · not yet recruiting
- NCT06992453 — Multi-omics Dissection of Gut Microbiome Engraftment During FMT · NA · not yet recruiting
Other recruiting trials for Ulcerative Colitis
Currently open trials in the same condition.
- NCT07185009 — A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Acti · Phase 3 · recruiting
- NCT07265570 — Study Evaluating ISM5411 Administered Orally to Subjects With Active Ulcerative Colitis (BETHESDA) · Phase 2 · recruiting
- NCT07223424 — Patient Preference for Subcutaneous vs. Intravenous Immune Therapy · Phase 2 · recruiting
- NCT06405087 — A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD · Phase 3 · recruiting
- NCT07184996 — An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Activ · Phase 3 · recruiting
Other Joint Authority for Päijät-Häme Social and Health Care trials
Trials by the same sponsor.
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- NCT05005117 — Laparoscopic Approach for Emergency Colon Resection · NA · recruiting
- NCT04564105 — Simulation Training and Teamwork Concerning Intubation on the Icu · NA · completed
- NCT05025319 — Optimization of Bedside Chest X-rays Taken in the Intensive Care Unit by Using Current Software-based Techniques · active not 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 NCT03561532 (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 Joint Authority for Päijät-Häme Social and Health Care
- Last refreshed: 15 August 2019
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/NCT03561532.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing