Effects of Faecal Microbiota Transplantation in Patients With IBS

NCT03822299 | Completed DMC

• 1 other identifier: HelseFonna
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (5)

• Global improvement in IBS symptoms as assessed by IBS Symptom Severity Scale (IBS-SSS)

  IBS-SSS is a visual assessment scale (VAS) rating from 0 to 100, with total scores ranging from 0 to 500. Lower scores indicate improvement.

  3 months.

• Global improvement in IBS symptoms as assessed by Birmingham Symptom scale questionnaire

  This questionnaire consists of 11 question. measured on a six-point Likert scale ranging from 0 to 5. Lower scores indicate improvement.

  3 months.

• Quality of life as assessed by IBS quality of life (IBSQoL) questionnaire

  IBSQoL consist of 34- questions measured on a five-point Likert scale ranging from 0 to 5. Higher scores indicate improvement.

  3 months

• Quality of life as assessed by Short form of Nepean Dyspepsia Index (SF-NDI) questionnaires

  SF-NDI is a five-point Likert scale ranging from 0 to 5. Lower scores indicate improvement.

  3 months

• Fatigue as assessed by: Fatigue Assessment Scale (FAS) questionnaire

  FAS is a five-point Likert scale ranging from 0 to 5. Lower scores indicate improvement.

  3 months

Secondary Outcomes (1)

• Stool microbiota changes as assessed by the Dysbiosis index (DI)

  3 months.

Other Outcomes (1)

• Adverse events

  up to the end point (3 months)

Study Arms (3)

Placebo

NO INTERVENTION

Patients receive suspension of their own feces.

30 g donor dose

ACTIVE COMPARATOR

Patients receiving 30 g of a healthy donor feces.

Dietary Supplement: healthy feces microbiota

60 g donor dose

ACTIVE COMPARATOR

Patients receiving 60 g of a healthy donor feces.

Dietary Supplement: healthy feces microbiota

Interventions

healthy feces microbiota DIETARY_SUPPLEMENT

Suspension of healthy feces microbiota in sterile saline solution

Also known as: placebo

30 g donor dose; 60 g donor dose

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between who fulfill Rome IV criteria for the diagnosis of IBS.
• Patients with moderate to severe IBS symptoms (IBS-SSS ≥ 175).

You may not qualify if:

• Pregnant, planning pregnancy or lactating women.
• The use of antibiotics or probiotics within 1 month prior to FMT.
• Patients who had undergone any abdominal surgery, with the exception of appendectomy, cholecystectomy, Caesarean section or hysterectomy.

Sponsors & Collaborators

• Helse Fonna: lead
• Helse Vest: collaborator

Study Sites (1)

Helse Fonna

Haugesund, 5504, Norway

Location

Related Publications (7)

• El-Salhy M, Valeur J, Bronstad I, Gilja OH, Hatlebakk JG. Possible Role of Butyric Acid in Long-Term Symptom Relief in Irritable Bowel Syndrome Patients Following Fecal Microbiota Transplantation. Neurogastroenterol Motil. 2025 Dec;37(12):e70115. doi: 10.1111/nmo.70115. Epub 2025 Aug 1.

  PMID: 40751371 DERIVED

• El-Salhy M, Winkel R, Casen C, Hausken T, Gilja OH, Hatlebakk JG. Efficacy of Fecal Microbiota Transplantation for Patients With Irritable Bowel Syndrome at 3 Years After Transplantation. Gastroenterology. 2022 Oct;163(4):982-994.e14. doi: 10.1053/j.gastro.2022.06.020. Epub 2022 Jun 14.

  PMID: 35709830 DERIVED

• El-Salhy M, Mazzawi T, Hausken T, Hatlebakk JG. The fecal microbiota transplantation response differs between patients with severe and moderate irritable bowel symptoms. Scand J Gastroenterol. 2022 Sep;57(9):1036-1045. doi: 10.1080/00365521.2022.2064725. Epub 2022 Apr 29.

  PMID: 35486073 DERIVED

• El-Salhy M, Mazzawi T, Hausken T, Hatlebakk JG. Irritable bowel syndrome patients who are not likely to respond to fecal microbiota transplantation. Neurogastroenterol Motil. 2022 Sep;34(9):e14353. doi: 10.1111/nmo.14353. Epub 2022 Mar 18.

  PMID: 35302268 DERIVED

• El-Salhy M, Kristoffersen AB, Valeur J, Casen C, Hatlebakk JG, Gilja OH, Hausken T. Long-term effects of fecal microbiota transplantation (FMT) in patients with irritable bowel syndrome. Neurogastroenterol Motil. 2022 Jan;34(1):e14200. doi: 10.1111/nmo.14200. Epub 2021 Jun 18.

  PMID: 34145677 DERIVED

• El-Salhy M, Valeur J, Hausken T, Gunnar Hatlebakk J. Changes in fecal short-chain fatty acids following fecal microbiota transplantation in patients with irritable bowel syndrome. Neurogastroenterol Motil. 2021 Feb;33(2):e13983. doi: 10.1111/nmo.13983. Epub 2020 Sep 17.

  PMID: 32945066 DERIVED

• El-Salhy M, Hatlebakk JG, Gilja OH, Brathen Kristoffersen A, Hausken T. Efficacy of faecal microbiota transplantation for patients with irritable bowel syndrome in a randomised, double-blind, placebo-controlled study. Gut. 2020 May;69(5):859-867. doi: 10.1136/gutjnl-2019-319630. Epub 2019 Dec 18.

  PMID: 31852769 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Haldis Lier, MD, PhD

  Head of Research Department at Helse Finna HF

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A research nurse, not involved in the trial, create the allocation sequence using a website. This was done in blocks of 21 patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor/Consultant gatroenterologist

Model Details: Intervention. Dietary supplement: fecal suspension. Healthy donor or own faeces (placebo) administrated through working canal of a gastroscope.

Study Record Dates

• First Submitted: December 21, 2018
• First Posted: January 30, 2019
• Study Start: January 1, 2018
• Primary Completion: April 30, 2019
• Study Completion: May 5, 2019
• Last Updated: May 7, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)