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NCT04926103: FUEL
Screening Donors, Fecal Microbiota Transplant Program in Ulcerative Colitis
NA trial testing Fecal Microbiota transplant (FMT) in Ulcerative Colitis Flare in 200 participants. Currently enrolling.
1 October 2028
Quick facts
| Lead sponsor | Hamilton Health Sciences Corporation |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 200 |
| Start date | 1 July 2022 |
| Primary completion | 1 October 2028 |
| Estimated completion | 1 May 2029 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Fecal Microbiota transplant (FMT) — full drug profile →
Conditions studied
- Ulcerative Colitis Flare — all drugs for Ulcerative Colitis Flare →
Sponsor
Hamilton Health Sciences Corporation — full company profile →
Who can join
18 and older, any sex, with Ulcerative Colitis Flare. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The investigators intend to screen for new donors, given that there may a donor effect (PubMed ID: 25857665), with some donors not inducing remission in any patient whilst others inducing remission in 20-40% of cases. It is important to give UC patients participating in RCTs stool that has been demonstrated to be effective in some patients. We therefore propose to conduct an open label study in patients with active UC to ensure new donors are effective at inducing remission in some patients. Patients that have FMT will relapse within 18 months (PubMed ID: 25857665) although further FMT therapy induces remission so it is possible that maintenance FMT will result in long term remission, but this needs evaluation. We will therefore follow UC patients that have responded to FMT long term in this open label study.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04926103
- Europe PMC full search
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Related trials
Other recruiting trials for Ulcerative Colitis Flare
Currently open trials in the same condition.
- NCT05466890 — Phase 2a to Evaluate PL-8177 in Subjects with Active Ulcerative Colitis (UC) · Phase 2 · active not recruiting
- NCT04276740 — MARVEL: Mitochondrial Anti-oxidant Therapy to Resolve Inflammation in Ulcerative Colitis · Phase 2 · active not recruiting
Other Hamilton Health Sciences Corporation trials
Trials by the same sponsor.
- NCT06567808 — Prevention of Infections in Cardiac Surgery (PICS): a Cluster-randomized Factorial Cross-over Trial · Phase 4 · not yet recruiting
- NCT07118696 — Evaluating a Shorter, Rifampicin-Based Treatment for People With Less Severe Tuberculosis Disease · Phase 3 · not yet recruiting
- NCT07027436 — Radiation Therapy Followed by Durvalumab (MEDI4736) and Tremelimumab And Surgery Versus Radiation Therapy Followed by Su · Phase 3 · not yet recruiting
- NCT06908694 — Investigation of GLP1-Receptor Agonists in Men With Prostate Cancer Taking Androgen Deprivation Therapy · Phase 4 · recruiting
- NCT06836024 — A Trial of Actazin Versus PEG 3350 for Maintenance Therapy in Children With Constipation · Phase 2, PHASE3 · 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 NCT04926103 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hamilton Health Sciences Corporation
- Last refreshed: 1 October 2024
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/NCT04926103.
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