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NCT04236843
Faecal Microbiota Transplantation (FMT) in Patients With IBSmechanism(s) of Action
NA trial testing Feces in Irritable Bowel Syndrome in 186 participants. Completed in 25 March 2022.
25 March 2022
Quick facts
| Lead sponsor | Helse Fonna |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 186 |
| Start date | 3 February 2020 |
| Primary completion | 25 March 2022 |
| Estimated completion | 25 March 2022 |
| Sites | 1 location across Norway |
Drugs / interventions tested
- Feces
Conditions studied
- Irritable Bowel Syndrome — all drugs for Irritable Bowel Syndrome →
Sponsor
Helse Fonna — full company profile →
Who can join
Adults 18 to 75, any sex, with Irritable Bowel Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Two hundrad patients are randomized to either 90 g transplant, 90 g transplant twice with 1week interval into the distal small intestine via working channel of a gastroscope, or to 90 g transplant into the coecum of the colon via working channel of a colonoscope. The patients shall complete 5 questionnaires measuring symptoms, fatigue and quality of life and collect a feces sample at the baseline, and at 3, 6 and 12 months after FMT. Dysbiosis and fecal bacterial are determined by using 16S rRNA gene.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Factors affecting the outcome of fecal microbiota transplantation for patients with irritable bowel syndrome.
El-Salhy M, Gilja OH, Hatlebakk JG. · · 2024 · cited 13× · PMID 37427566 · DOI 10.1111/nmo.14641 -
Factors underlying the long-term efficacy of faecal microbiota transplantation for patients with irritable bowel syndrome.
El-Salhy M, Gilja OH, Hatlebakk JG. · · 2024 · cited 3× · PMID 38843950 · DOI 10.1016/j.micinf.2024.105372 -
Increasing the transplant dose and repeating faecal microbiota transplantation results in the responses of male patients with IBS reaching those of females.
El-Salhy M, Gilja OH, Hatlebakk JG. · · 2024 · cited 2× · PMID 38084725 · DOI 10.1080/00365521.2023.2292479 -
Factors Underlying the Difference in Response to Fecal Microbiota Transplantation Between IBS Patients with Severe and Moderate Symptoms.
El-Salhy M, Hatlebakk JG. · · 2024 · cited 1× · PMID 38446309 · DOI 10.1007/s10620-024-08369-x
Verify or expand the search:
- PubMed search for NCT04236843
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Irritable Bowel Syndrome
Currently open trials in the same condition.
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- NCT07360938 — Drug Interaction Potential of Pro-Inflammatory Conditions · recruiting
- NCT06788444 — Efficacy of Esketamine for Patients With Irritable Bowel Syndrome · NA · recruiting
- NCT07484412 — Efficacy and Safety of Encapsulated Bifidobacterium Longum BBH016 in Subjects With Lower Gastrointestinal Symptoms · NA · active not recruiting
Other Helse Fonna trials
Trials by the same sponsor.
- NCT07433491 — Blue-blocking Glasses for Sleep Disorders in Child and Adolescent Psychiatry · NA · not yet recruiting
- NCT03864094 — Hemodynamics During Induction of General Anesthesia After Prophylactic Ephedrine, Phenylephrine or Norepinephrine. · Phase 4 · completed
- NCT04588285 — Ambroxol in New and Early DLB, A Phase IIa Multicentre Randomized Controlled Double Blind Clinical Trial · Phase 2 · unknown
- NCT03861377 — Hemodynamics During Induction of General Anesthesia With Medium or Low Remifentanil Doses. · Phase 4 · completed
- NCT03861364 — Hemodynamics During Induction of General Anesthesia With High and Low Propofol Dose. · Phase 4 · 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 NCT04236843 (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 Helse Fonna
- Last refreshed: 22 August 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/NCT04236843.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing