NCT03822299

Effects of Faecal Microbiota Transplantation in Patients With IBS

Completed NA Last updated 7 May 2019

What this trial tests

NA trial testing healthy feces microbiota in Irritable Bowel Syndrome in 164 participants. Completed in 5 May 2019.

Timeline

1 January 2018

Primary endpoint
30 April 2019

5 May 2019

Quick facts

Lead sponsor	Helse Fonna
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	164
Start date	1 January 2018
Primary completion	30 April 2019
Estimated completion	5 May 2019
Sites	1 location across Norway

Drugs / interventions tested

• healthy feces microbiota

Conditions studied

• Irritable Bowel Syndrome — all drugs for Irritable Bowel Syndrome →

Sponsor

Helse Fonna — full company profile →

Who can join

Adults 18 to 85, any sex, with Irritable Bowel Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Irritable bowel syndrom (IBS) is a common chronic gastrointestinal disorder that affects 10-20% of the world population. The prevalence of IBS in Norway is between 8% and 25%. The pathophysiology of IBS is incompletely understood, and there is no effective treatment for this condition. Imbalance (dysbiosis) of the gut microbiome has been found in patients with IBS. In the absence of effective method to restore the dysbiosis, transplantation of a microbiome from healthy individuals with well-functioning gut (FMT) to those with IBS has been performed. Two randomized double blind placebo-controlled (RCT) studies have been published recently. Whereas it was reported in one study that FMT reduced symptom and improved quality of life in patients with IBS, FMT had no effect in the other study. In order to clarify these contradictory results, a new RCT study that enrolled larger number of patients is required. In this study, the investigators intend to recruit 170 IBS patients from those attending outdoor clinic at Stord hospital in a randomized, double blind placebo trial. A single healthy donor with well-characterized microbiome is going to be used. The effects on symptoms, quality of life, fatigue as well as dysbiosis before and after FMT are going to be investigated. The possible mechanisms behind the effects if any of FMT such as changes in intestinal stem cells, enteroendocrine cells and local immune defense shall be also investigated. The patients are going to be randomized either to placebo (own faces), 30 g or 60 g of the donor faces in ratio 1:1:1.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Efficacy of faecal microbiota transplantation for patients with irritable bowel syndrome in a randomised, double-blind, placebo-controlled study.
   El-Salhy M, Hatlebakk JG, Gilja OH, Bråthen Kristoffersen A, et al · · 2020 · cited 342× · PMID 31852769 · DOI 10.1136/gutjnl-2019-319630
2. Gut Microbiome-Brain Alliance: A Landscape View into Mental and Gastrointestinal Health and Disorders.
   Sasso JM, Ammar RM, Tenchov R, Lemmel S, et al · · 2023 · cited 100× · PMID 37156006 · DOI 10.1021/acschemneuro.3c00127
3. Changes in fecal short-chain fatty acids following fecal microbiota transplantation in patients with irritable bowel syndrome.
   El-Salhy M, Valeur J, Hausken T, Gunnar Hatlebakk J. · · 2021 · cited 61× · PMID 32945066 · DOI 10.1111/nmo.13983
4. Efficacy of Fecal Microbiota Transplantation for Patients With Irritable Bowel Syndrome at 3 Years After Transplantation.
   El-Salhy M, Winkel R, Casen C, Hausken T, et al · · 2022 · cited 49× · PMID 35709830 · DOI 10.1053/j.gastro.2022.06.020
5. Dietary Regulation of Gut-Brain Axis in Alzheimer's Disease: Importance of Microbiota Metabolites.
   Frausto DM, Forsyth CB, Keshavarzian A, Voigt RM. · · 2021 · cited 39× · PMID 34867153 · DOI 10.3389/fnins.2021.736814
6. Increasing the Dose and/or Repeating Faecal Microbiota Transplantation (FMT) Increases the Response in Patients with Irritable Bowel Syndrome (IBS).
   El-Salhy M, Hausken T, Hatlebakk JG. · · 2019 · cited 35× · PMID 31238507 · DOI 10.3390/nu11061415
7. Responses to faecal microbiota transplantation in female and male patients with irritable bowel syndrome.
   El-Salhy M, Casen C, Valeur J, Hausken T, et al · · 2021 · cited 34× · PMID 34025075 · DOI 10.3748/wjg.v27.i18.2219
8. Long-term effects of fecal microbiota transplantation (FMT) in patients with irritable bowel syndrome.
   El-Salhy M, Kristoffersen AB, Valeur J, Casen C, et al · · 2022 · cited 32× · PMID 34145677 · DOI 10.1111/nmo.14200