Clinical Trials Study
Copyright ©The Author(s) 2018. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Mar 21, 2018; 24(11): 1259-1268
Published online Mar 21, 2018. doi: 10.3748/wjg.v24.i11.1259
Low-FODMAP vs regular rye bread in irritable bowel syndrome: Randomized SmartPill® study
Laura Pirkola, Reijo Laatikainen, Jussi Loponen, Sanna-Maria Hongisto, Markku Hillilä, Anu Nuora, Baoru Yang, Kaisa M Linderborg, Riitta Freese
Laura Pirkola, Riitta Freese, Division of Nutrition, Department of Food and Environmental Sciences, University of Helsinki, Helsinki FI-00790, Finland
Laura Pirkola, Jussi Loponen, Sanna-Maria Hongisto, Fazer Group/ Fazer Bakeries Ltd, Vantaa FI-01230, Finland
Reijo Laatikainen, Medical Faculty, Pharmacology, Medical Nutrition Physiology, University of Helsinki, Helsinki FI-00290, Finland
Markku Hillilä, Clinic of Gastroenterology, University of Helsinki and Helsinki University, Hospital Jorvi, Espoo FI-02740, Finland
Anu Nuora, Baoru Yang, Kaisa M Linderborg, Food Chemistry and Food Development, Department of Biochemistry, University of Turku, Turku FI-20014, Finland
Author contributions: Pirkola L, Freese R, Laatikainen R, Hongisto SM, Loponen J, Linderborg KM, and Hillilä M contributed to the design and practical implementation of the study; the research was performed by Pirkola L; the University of Turku team (Linderborg KM, Nuora A, and Yang B) provided the SmartPill equipment and related technical assistance; data analyses were performed by Pirkola L and Freese R. The manuscript was written by Laatikainen R, Pirkola L, and Freese R; all authors critically revised the manuscript; the authors had complete access to the data that supports the publication; all authors have approved the final version of the manuscript.
Clinical trial registration statement: ISRCTN registry (ISRCTN11005234).
Informed consent statement: All participants signed the informed consent form.
Conflict-of-interest statement: Laatikainen R has written a Finnish book on irritable bowel syndrome and diet; He is also founder and owner of Booston Ltd, which provides IBS-related dietetic services to IBS patients, healthcare professionals, and various organizations; Pirkola L, Hongisto SM, and Loponen J are employees of Fazer Bakeries; At the time of the research, Pirkola L was working at the University of Helsinki; Others have no personal interests to declare; Fazer Bakeries funded the study and provided the breads.
Data sharing statement: Patient-level data available upon request.
CONSORT 2010 statement: Aligned with CONSORT 2010.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (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/
Correspondence to: Laura Pirkola, MSc, Fazer Group/Fazer Bakeries Ltd, Fazerintie 6, Vantaa FI-01230, Finland. laura.pirkola@fazer.com
Telephone: +358-40-6564887
Received: January 11, 2018
Peer-review started: January 11, 2018
First decision: February 26, 2018
Revised: March 1, 2018
Accepted: March 3, 2018
Article in press: March 3, 2018
Published online: March 21, 2018
Processing time: 64 Days and 3.6 Hours
ARTICLE HIGHLIGHTS
Research background

FODMAPs are rapidly fermentable carbohydrates shown to aggravate gastrointestinal symptoms in irritable bowel syndrome (IBS). A major challenge in the research of IBS is the lack of objective markers of disease activity. Excretion of hydrogen and methane and colonic fermentation markers are among the rare easily available and objective markers of gastrointestinal circumstances during the consumption of FODMAPs or other poorly absorbable carbohydrates. Grains are often considered as triggers of irritable bowel syndrome symptoms but less is known about the effects of grain products with differing content of FODMAPs on gastrointestinal transit times, pH and intraluminal pressure in patients with IBS.

Research motivation

SmartPill, a motility monitoring capsule, which measures intraluminal pH, transit time and pressure, and might thus offer the means to gather objective data on gastrointestinal conditions in IBS patients. A combination of SmartPill data and measurements of perceived symptoms may improve our understanding on the etiology of IBS symptoms when consuming grains high in FODMAPs.

Research objectives

Our aim was to evaluate if rye bread low in FODMAPs would cause less hydrogen excretion, lower intraluminal pressure, higher colonic pH and less IBS symptoms than regular rye bread.

Research methods

The study was conducted as a randomized double blind controlled cross-over meal study. Female IBS patients (n = 7) ate study breads on 3 consecutive meals. Intraluminal conditions were measured by SmartPill®, an indigestible motility capsule.

Research results

Postprandial hydrogen excretion, a marker of colonic fermentation, expressed as AUC(0-630 min) was [median (range)] 6300 (1785-10800) for low-FODMAP rye bread and 10635 (4215-13080) ppm∙min for regular bread (P = 0.028). The means of the visual analogue scale measurements of individual gastrointestinal symptoms did not show any statistically significant differences between the breads. Intraluminal pressure correlated significantly with total symptom score after regular rye bread (ρ = 0.786, P = 0.036) and nearly significantly after low-FODMAP bread consumption (ρ = 0.75, P = 0.052). We found no differences in pH, contractions or transit times between the breads. Gastric emptying of SmartPill was slower than expected on the basis of majority of research literature.

Research conclusions

Our meal study demonstrated that low-FODMAP rye bread reduces colonic fermentation but no difference was found in median values of symptoms, pH, colonic pressure of gastrointestinal tract when compared to regular rye bread. Our observation on the correlation between increased intra-colonic pressure and symptom severity warrants further studies in IBS.

Research perspectives

Our finding on the correlation of intracolonic pressure and symptom severity suggests that IBS symptoms might be worsened by any reason that leads to increased colonic pressure in IBS. Consequently, any therapeutic attempts to reduce intraluminal pressure and contractions might continue to be important therapeutic targets in IBS. The study also implied that SmartPill might not be an optimal device to evaluate the gastrointestinal circumstances during meal studies among IBS patients lasting less than 24 h, due to device’s inability to measure effects of a singular food bolus in a timely manner. Observation and feeding periods longer than 38 h are recommended for future research utilizing SmartPill, especially among people with IBS.