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NCT06254625
Fecal Transplantation in Patients Colonic Diverticulitis
Phase 1 trial testing Fecal Microbiome in Diverticulitis, Colonic in 40 participants. Not yet recruiting.
31 October 2024
Quick facts
| Lead sponsor | Odense University Hospital |
|---|---|
| Phase | Phase 1 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 1 April 2024 |
| Primary completion | 31 October 2024 |
| Estimated completion | 31 December 2024 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Fecal Microbiome — full drug profile →
- Placebo
Conditions studied
- Diverticulitis, Colonic — all drugs for Diverticulitis, Colonic →
- Colon Inflamed — all drugs for Colon Inflamed →
Sponsor
Odense University Hospital
Who can join
18 and older, any sex, with Diverticulitis, Colonic or Colon Inflamed. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical trial is to investigate the safety and effect of fecal microbiome transplantation (FMT) in patients with a former episode of acute colonic diverticulitis. The main question\[s\] it aims to answer are: * Is FMT in patients with a former episode of acute colonic diverticulitis a safe procedure without severe adverse events * What is the impact of FMT on patient-reported outcomes and re-admission rate Participants will be asked to: * to ingest either 25-30 capsules with FMT or placebo capsules * Fill-in GI-QLI questionnaire prior to treatment/placebo and 3 months post baseline * Fill-in eating habit questionnaire * deliver blood-and stool samples prior to treatment/placebo and 3 months post baseline * In both the treatment and placebo group 5 patients will be offered sigmoideoscopy for mucosal biopsies if it is more than 2 items\]. If there is a comparison group: Researchers will compare \[insert groups\] to see if \[insert effects\]
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Safety and efficacy of faecal microbiota transplantation in patients with acute uncomplicated diverticulitis: study protocol for a randomised placebo-controlled trial.
Thorndal C, Kragsnaes MS, Nilsson AC, Holm DK, et al · · 2025 · PMID 39758967 · DOI 10.1177/17562848241309868
Verify or expand the search:
- PubMed search for NCT06254625
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Diverticulitis, Colonic
Currently open trials in the same condition.
- NCT06287671 — Colorectal Omics and OfCS Proteoglycans · recruiting
Other Odense University Hospital trials
Trials by the same sponsor.
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- NCT07191379 — Self-administered Subcutaneous Daratumumab in Patients With Multiple Myeloma · Phase 4 · not yet recruiting
- NCT07170085 — Positioning of Children With Acute Respiratory Insufficiency · NA · 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 NCT06254625 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 Odense University Hospital
- Last refreshed: 5 April 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/NCT06254625.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing