Last reviewed · How we verify

NCT04236843

Faecal Microbiota Transplantation (FMT) in Patients With IBSmechanism(s) of Action

Completed NA Last updated 22 August 2023
What this trial tests

NA trial testing Feces in Irritable Bowel Syndrome in 186 participants. Completed in 25 March 2022.

Timeline
3 February 2020
Primary endpoint
25 March 2022
25 March 2022

Quick facts

Lead sponsorHelse Fonna
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment186
Start date3 February 2020
Primary completion25 March 2022
Estimated completion25 March 2022
Sites1 location across Norway

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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
  4. 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:

Other recruiting trials for Irritable Bowel Syndrome

Currently open trials in the same condition.

Other Helse Fonna trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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