The Effects of FODMAPs in Patients With Irritable Bowel Syndrome

Last updated: January 10, 2022
Sponsor: Sahlgrenska University Hospital, Sweden
Overall Status: Completed

Phase

N/A

Condition

Gastrointestinal Diseases And Disorders

Lactose Intolerance

Colic

Treatment

N/A

Clinical Study ID

NCT05182593
394-18
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients with IBS according to Rome IV criteria

Exclusion

Exclusion Criteria:

  • allergy or documented intolerance to food
  • severe cardiovascular disease
  • severe hepatic disease
  • severe neurological disease
  • severe psychiatric disease
  • celiac disease
  • inflammatory bowel diseases
  • diabetes
  • bowel dysfunction related to previous surgery
  • pregnant or lactating women
  • use of antibiotics within four weeks before inclusion
  • strict avoidance of foods

Study Design

Total Participants: 30
Study Start date:
February 01, 2019
Estimated Completion Date:
September 01, 2020

Study Description

The study is a randomized, double-blind, cross-over trial.

The aim is to assess the effects of low fermentable oligosaccharides, disaccharides, 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-blinded, cross-over study. The subjects will start with the low FODMAP diet or moderate/high FODMAP diet and cross over to the other intervention (both for 7 days). In between the interventions, there is a wash-out period of at least 14 days. The subjects will receive ready-made meals from the hospital kitchen (lunch and dinner) and in between snacks. The subjects are instructed to buy breakfast themselves and the subjects will receive information on which other foods to avoid, without mentioning 'FODMAPs'. The subjects will follow their usual diet (as before initiation of the study) during the wash-out 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 Symptom 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 assessed by questionnaires, including Central Sensitization Index (CSI), Hospital Anxiety and Depression Scale (HADS), Patient Health Questionnaire (PHQ)-15 and Visceral Sensitivity Index (VSI).

Connect with a study center

  • Magnus Simren

    Gothenburg, Non-US/Non-Canadian 44331
    Sweden

    Site Not Available

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