Last reviewed · How we verify
NCT05829109
Safety and Efficacy of Healthy to Inflamed Pouch Fecal Microbiota Transplantation
EARLY_PHASE1 trial testing Fecal Microbiota Transplant (FMT) in Chronic Pouchitis in 16 participants. Currently enrolling.
1 December 2026
Quick facts
| Lead sponsor | Maia Kayal |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 16 |
| Start date | 1 September 2024 |
| Primary completion | 1 December 2026 |
| Estimated completion | 1 December 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Fecal Microbiota Transplant (FMT) — full drug profile →
Conditions studied
- Chronic Pouchitis — all drugs for Chronic Pouchitis →
- Pouchitis — all drugs for Pouchitis →
Sponsor
Maia Kayal
Who can join
18 and older, any sex, with Chronic Pouchitis or Pouchitis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Number of patients with FMT related adverse events
Time frame: 8 weeks
The number of patients with FMT related adverse events through week 8 classified according to the Medical Dictionary for Regulatory Activities (MedDRA) and categorized according to the NIH Criteria for Adverse Events.
Sponsor's own description
The purpose of this research study is to assess the safety and efficacy of fecal microbiota transplant (FMT) in the treatment of chronic pouchitis.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Are Small Molecules Effective in Treating Inflammatory Pouch Disorders Following Ileal Pouch-Anal Anastomosis for Ulcerative Colitis? Here Is Where We Stand.
Gravina AG, Pellegrino R, Palladino G, Imperio G, et al · · 2024 · cited 6× · PMID 39334930 · DOI 10.3390/biom14091164
Verify or expand the search:
- PubMed search for NCT05829109
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Fecal Microbiota Transplant (FMT)
Trials testing the same drug.
- NCT06960122 — Clinical Study on Fecal Microbiota Transplantation for Diarrhea After Total Pancreatectomy · NA · not yet recruiting
- NCT06924645 — Fecal Microbiota Transplantation for Preventing Gastrointestinal Symptoms in Extrapulmonary Neuroendocrine Neoplasms: A · NA · not yet recruiting
- NCT05286294 — Microbiota Transplant to Cancer Patients Who Have Failed Immunotherapy Using Faeces From Clinical Responders · Phase 2 · active not recruiting
- NCT06938165 — The Safety and Efficacy of Fecal Microbiota Transplant (FMT) for Steroid-refractory Graft-versus-host Disease · NA · completed
- NCT03678493 — A Study of FMT in Patients With AML Allo HSCT in Recipients · Phase 2 · completed
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 NCT05829109 (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 Maia Kayal
- Last refreshed: 10 July 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/NCT05829109.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing