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
Abstract
AIM

To compare the effects of regular vs low-FODMAP rye bread on irritable bowel syndrome (IBS) symptoms and to study gastrointestinal conditions with SmartPill®.

METHODS

Our aim was to evaluate if rye bread low in FODMAPs would cause reduced hydrogen excretion, lower intraluminal pressure, higher colonic pH, different transit times, and fewer IBS symptoms than regular rye bread. The study was a randomized, double-blind, controlled cross-over meal study. Female IBS patients (n = 7) ate study breads at three consecutive meals during one day. The diet was similar for both study periods except for the FODMAP content of the bread consumed during the study day. Intraluminal pH, transit time, and pressure were measured by SmartPill, an indigestible motility capsule.

RESULTS

Hydrogen excretion (a marker of colonic fermentation) expressed as area under the curve (AUC)(0-630 min) was [median (range)] 6300 (1785-10800) ppm∙min for low-FODMAP rye bread and 10 635 (4215-13080) ppm∙min for regular bread (P = 0.028). Mean scores of gastrointestinal symptoms showed no statistically significant differences but suggested less flatulence after low-FODMAP bread consumption (P = 0.063). 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, pressure, or transit times between the breads. Gastric residence of SmartPill was slower than expected. SmartPill left the stomach in less than 5 h only during one measurement (out of 14 measurements in total) and therefore did not follow on par with the rye bread bolus.

CONCLUSION

Low-FODMAP rye bread reduced colonic fermentation vs regular rye bread. No difference was found in median values of intraluminal conditions of the gastrointestinal tract.

Keywords: Colonic pressure, FODMAP, Irritable bowel syndrome, Rye, Wireless motility capsule, Symptom severity

Core tip: Our study confirmed that low-FODMAP rye bread reduces colonic fermentation in irritable bowel syndrome (IBS) patients compared with regular rye bread. The observed correlation between increased intracolonic pressure and symptom severity underlines the central role of visceral sensitivity in IBS and suggests that some IBS symptoms might be exacerbated by any pathophysiological reason that leads to increased colonic pressure. The study also suggests that SmartPill might not be an optimal device to evaluate gastrointestinal circumstances during meal studies lasting less than 24 h, due to device’s inability to measure effects of a singular food bolus in a timely manner.