Clinical Trials Study
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. May 14, 2021; 27(18): 2219-2237
Published online May 14, 2021. doi: 10.3748/wjg.v27.i18.2219
Responses to faecal microbiota transplantation in female and male patients with irritable bowel syndrome
Magdy El-Salhy, Christina Casen, Jørgen Valeur, Trygve Hausken, Jan Gunnar Hatlebakk
Magdy El-Salhy, Department of Medicine, Stord Helse-Fonna Hospital, Stord 5416, Norway
Magdy El-Salhy, Trygve Hausken, Jan Gunnar Hatlebakk, Department of Clinical Medicine, University of Bergen, Bergen 5020, Norway
Magdy El-Salhy, Trygve Hausken, Jan Gunnar Hatlebakk, National Centre for Functional Gastrointestinal Disorders, Department of Medicine, Haukeland University Hospital, Bergen 5020, Norway
Christina Casen, Genetic Analysis AS, Oslo 0485, Norway
Jørgen Valeur, Unger-Vetlesen Institute, Lovisenberg Diaconal Hospital, Oslo 0440, Norway
Author contributions: El-Salhy M designed the study, obtained the funding, administered the study, recruited the patients, performed faecal microbiota transplantation, collected, analyzed and interpreted the data, and drafted the manuscript; Casen C contributed to the design of the study, analyzed the faecal bacteria and critically revised the manuscript for important intellectual content; Valeur J contributed to the design of the study, analyzed the short-chain fatty acids and critically revised the manuscript for important intellectual content; Hausken T and Hatlebakk JG contributed to the design of the study and to the analysis and interpretation of the data, and critically revised the manuscript for important intellectual content.
Institutional review board statement: The study was reviewed and approved by the Institutional Review Board of the University of Bergen.
Clinical trial registration statement: This study is registered at www.clinicaltrials.gov (NCT03822299) and www.cristin.no (ID657402).
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrolment.
Conflict-of-interest statement: The authors declare that they have no conflict of interest.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Magdy El-Salhy, BSc, MD, PhD, Chief Doctor, Professor, Department of Medicine, Stord Helse-Fonna Hospital, Tysevegen 64, Stord 5416, Norway. magdy.elsalhy@sklbb.no
Received: January 25, 2021
Peer-review started: January 25, 2021
First decision: February 27, 2021
Revised: March 13, 2021
Accepted: April 22, 2021
Article in press: April 22, 2021
Published online: May 14, 2021
Abstract
BACKGROUND

Faecal microbiota transplantation (FMT) seems to be a promising treatment for irritable bowel syndrome (IBS) patients. In Western countries (United States and Europe), there is a female predominance in IBS. A sex difference in the response to FMT has been reported recently in IBS patients.

AIM

To investigate whether there was a sex difference in the response to FMT in the IBS patients who were included in our previous randomized controlled trial of the efficacy of FMT.

METHODS

The study included 164 IBS patients who participated in our previous randomized controlled trial. These patients had moderate-to-severe IBS symptoms belonging to the IBS-D (diarrhoea-predominant), IBS-C (constipation-predominant) and IBS-M (mixed) subtypes, and had not responded to the National Institute for Health and Care Excellence (NICE)-modified diet. They belonged in three groups: placebo (own faeces), and active treated group (30-g or 60-g superdonor faeces). The patients completed the IBS severity scoring system (IBS-SSS), Fatigue Assessment Scale (FAS) and the IBS quality of life scale (IBS-QoL) questionnaires at the baseline and 2 wk, 1 mo and 3 mo after FMT. They also provided faecal samples at the baseline and 1 mo after FMT. The faecal bacteria profile and dysbiosis were determined using the 16S rRNA gene polymerase chain reaction DNA amplification covering V3-V9; probe labelling by single nucleotide extension and signal detection. The levels of short-chain fatty acids (SCFAs) were determined by gas chromatography and flame ionization.

RESULTS

There was no sex difference in the response to FMT either in the placebo group or active treated group. There was no difference between females and males in either the placebo group or actively treated groups in the total score on the IBS-SSS, FAS or IBS-QoL, in dysbiosis, or in the faecal bacteria or SCFA level. However, the response rate was significantly higher in females with diarrhoea-predominant (IBS-D) than that of males at 1 mo, and 3 mo after FMT. Moreover, IBS-SSS total score was significantly lower in female patients with IBS-D than that of male patients both 1 mo and 3 mo after FMT.

CONCLUSION

There was no sex difference in the response to FMT among IBS patients with moderate-to-severe symptoms who had previously not responded to NICE-modified diet. However, female patients with IBS-D respond better and have higher reduction of symptoms than males after FMT.

Keywords: Dysbiosis, Fatigue, Microbiome, Quality of life, Short-chain fatty acids, Superdonor

Core Tip: A sex difference in the response to faecal microbiota transplantation (FMT) was previous reported for a subgroup of refractory irritable bowel syndrome (IBS) patients with severe bloating who had not responded to at least three conventional therapies for IBS. This subgroup only contained patients with diarrhoea-predominant (IBS-D) or mixed (IBS-M) IBS. The present study found no sex difference in the response to FMT among IBS patients with moderate-to-severe symptoms of IBS-D, constipation-predominant (IBS-C) and IBS-M. However, female patients with IBS-D respond better and have higher reduction of symptoms than males after FMT.