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Clinical Trial Summary

Patients with Irritable Bowel Syndrome (IBS) often link their symptoms to foods. Interest in dietary management recently increased, including the use of a low FODMAP diet. To investigate relation of FODMAPs and IBS, a randomized, double-blind, cross-over trial will be carried out in adult (>18) patients with IBS according to Rome IV criteria. The aim is to assess low FODMAP diet versus moderate/high FODMAP diet in IBS patients.

Clinical Trial Description

The study is a randomized, double-blind, cross-over trial. The aim is to assess the effects of low fermentable oligo-, di-, monosaccharides and polyols (FODMAP) diet compared to moderate/high FODMAP diet in IBS patients on gastrointestinal symptoms and psychological factors. The primary hypothesis is that the low FODMAP diet decreases gastrointestinal symptoms compared to moderate/high FODMAP diet, and that this change is accompanied with reduced psychological distress. IBS patients (Rome IV) are challenged with FODMAPs in this randomized, double-blind, cross-over study. They start with low FODMAP diet or moderate/high FODMAP diet and cross over to the other intervention (both for 7 days). In between there is a wash-out period of at least 14 days. The subjects will get meals (lunch and dinner) from the hospital kitchen. The subjects will follow a strict low FODMAP diet during both periods, they will receive information and which foods to avoid, without mentioning 'FODMAPs'. The subjects will eat and drink as before the study during the washout period. Primary outcomes are change in gastrointestinal symptoms, assessed by questionnaires, including IBS Severity Scoring System (IBS-SSS) (7-10 day recall and modified daily) and Gastrointestinal Symtom Rating Scale-IBS (GSRS-IBS). A 50-point reduction in IBS-SSS indicates clinical response. Bacterial fermentation (exhaled hydrogen and methane) and visceral sensitivity will be measured using the Lactulose-Nutrient Challenge Test. Secondary outcomes are change in psychological factors and ssessed by questionnaires, including CSI, HADS, PHQ-15 and VSI. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05182593
Study type Interventional
Source Sahlgrenska University Hospital, Sweden
Status Completed
Phase N/A
Start date February 1, 2019
Completion date September 1, 2020

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