Randomized Controlled Trial
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Sep 6, 2021; 9(25): 7417-7432
Published online Sep 6, 2021. doi: 10.12998/wjcc.v9.i25.7417
Clinical effectiveness of adding probiotics to a low FODMAP diet: Randomized double-blind placebo-controlled study
Beril Turan, Göksel Bengi, Ruksan Cehreli, Hale Akpınar, Müjde Soytürk
Beril Turan, Department of Internal Medicine, Dokuz Eylül University, Izmir 35000, Turkey
Göksel Bengi, Hale Akpınar, Müjde Soytürk, Department of Gastroenterology, Dokuz Eylul University Izmir, Izmir 35000, Turkey
Ruksan Cehreli, Department of Preventive Oncology, Dokuz Eylül University, Institute of Oncology, İzmir 35000, Turkey
Author contributions: Turan B, Soytürk M and Bengi G contributed equally to this work, designed the research and drafted the manuscript; Soytürk M and Akpınar H provided administrative and technical support; Çehreli R participated in the regulation, follow-up and evaluation of the diets of patients.
Institutional review board statement: The study was reviewed and approved by the Institutional Ethics committee of Dokuz Eylul University Izmir.
Clinical trial registration statement: This study was conducted with the approval of the Clinical Research Ethics Committee of Dokuz Eylul University (approval No. 2017/01-02) and the Medicines and Medical Devices Agency of the Ministry of Health of Turkey (approval No. 67116).
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: The authors declare that there are no conflicts of interest.
Data sharing statement: Technical appendix, statistical code, and dataset available from the corresponding author at soyturkmuj@gmail.com. Participants gave informed consent for data sharing.
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: Müjde Soytürk, MD, Professor, Department of Gastroenterology, Dokuz Eylul University Izmir, İnciraltı Mahallesi, Mithatpaşa Cd. İnciraltı yerleşkesi No. 1606, Izmir 35340, Turkey. soyturkmuj@gmail.com
Received: April 29, 2021
Peer-review started: April 29, 2021
First decision: May 26, 2021
Revised: June 15, 2021
Accepted: July 16, 2021
Article in press: July 16, 2021
Published online: September 6, 2021
Processing time: 123 Days and 20.8 Hours
Abstract
BACKGROUND

There are various studies showing the relationship between irritable bowel syndrome (IBS) and diet, and some dietary adjustments are recommended to reduce symptoms. In recent years, there is a growing number of studies that show a 4-8 wk low fermentable oligo, di- and mono-saccharides and polyols (FODMAP) diet has a 50%-80% significant effect on symptoms in IBS patients. There is strong evidence suggesting that changes in fecal microbiota have an impact on IBS pathogenesis. Based on this argument, probiotics have been used in IBS treatment for a long time. As is seen, the FODMAP diet and probiotics are used separately in IBS treatment.

AIM

To evaluate the effectiveness of adding probiotics to a low FODMAP diet to control the symptoms in patients with IBS.

METHODS

The patients who were admitted to the Gastroenterology Clinic of Dokuz Eylul University Hospital and diagnosed with IBS according to Rome IV criteria were enrolled into the study. They were randomized into 2 groups each of which consisted of 50 patients. All patients were referred to a dietitian to receive dietary recommendations for the low FODMAP diet with a daily intake of 9 g. The patients were asked to keep a diary of foods and beverages they consumed. The patients in Group 1 were given supplementary food containing probiotics (2 g) once a day in addition to their low FODMAP diet, while the patients in Group 2 were given a placebo once a day in addition to their low FODMAP diet. Visual analogue scale (VAS), the Bristol Stool Scale and IBS Symptom Severity Scale (IBS-SSS) scores were evaluated before and after the 21 d treatment.

RESULTS

The rate of adherence of 85 patients, who completed the study, to the FODMAP restricted diet was 92%, being 90% in Group 1 and 94% in Group 2. The mean scores of VAS and IBS-SSS of the patients in Group 1 before treatment were 4.6 ± 2.7 and 310.0 ± 78.4, respectively, and these scores decreased to 2.0 ± 1.9 and 172.0 ± 93.0 after treatment (both P < 0.001). The mean VAS and IBS-SSS scores of the patients in Group 2 before treatment were 4.7 ± 2.7 and 317.0 ± 87.5, respectively, and these scores decreased to 1.8 ± 2.0 and 175.0 ± 97.7 after treatment (both P < 0.001). The IBS-SSS score of 37 patients (86.04%) in Group 1 and 36 patients (85.71%) in Group 2 decreased by more than 50 points. Group 1 and Group 2 were similar in terms of differences in VAS and IBS-SSS scores before and after treatment. When changes in stool shape after treatment were compared using the Bristol Stool Scale, both groups showed significant change.

CONCLUSION

This study is the randomized controlled study to examine the efficiency of probiotic supplementation to a low FODMAP diet in all subtypes of IBS. The low FODMAP diet has highly positive effects on symptoms of all subtypes of IBS. It was seen that adding probiotics to a low FODMAP diet does not make an additional contribution to symptom response and adherence to the diet.

Keywords: Irritable bowel syndrome; Probiotics; Low Fermentable Oligo, Di- and Mono-Saccharides and Polyols diet; Visual Analogue Scale; the Bristol Stool Scale; Irritable Bowel Syndrome Symptom Severity Scale

Core Tip: A low fermentable oligo, di- and monosaccharides and polyols diet significantly relieved irritable bowel syndrome symptoms in all irritable bowel syndrome subtypes in the initial phase; however, adding probiotics to the diet did not make an additional contribution to symptom relief. Further longer term research using different probiotics is needed to examine the efficiency of probiotic supplementation to a low fermentable oligo, di- and monosaccharides and polyols diet in irritable bowel syndrome.