The Effects of FODMAPs in Patients With Irritable Bowel Syndrome

NCT ID: NCT05182593

Last Updated: 2022-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2020-09-01

Brief 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.

Detailed 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).

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Diet 1: moderate/high FODMAP diet. Diet 2: low FODMAP diet.

The subjects will follow the moderate/high FODMAP diet as the first intervention, and the low FODMAP diet as the second intervention. The subjects will follow both interventions for seven days.

Group Type: EXPERIMENTAL

Diet moderate/high in FODMAPs

Intervention Type: OTHER

The subjects will obtain meal boxes prepared in the hospital kitchen with a moderately high FODMAP content (23 grams/day)

Diet low in FODMAPs

Intervention Type: OTHER

The subjects will obtain meal boxes prepared in the hospital kitchen with a low FODMAP content (\<5 grams/day)

Diet 1: low FODMAP diet. Diet 2: moderate/high FODMAP diet.

The subjects will follow the low FODMAP diet as the first intervention, and the moderate/high FODMAP diet as the second intervention. The subjects will follow both interventions for seven days.

Group Type: EXPERIMENTAL

Diet moderate/high in FODMAPs

Intervention Type: OTHER

The subjects will obtain meal boxes prepared in the hospital kitchen with a moderately high FODMAP content (23 grams/day)

Diet low in FODMAPs

Intervention Type: OTHER

The subjects will obtain meal boxes prepared in the hospital kitchen with a low FODMAP content (\<5 grams/day)

Interventions

Diet moderate/high in FODMAPs

The subjects will obtain meal boxes prepared in the hospital kitchen with a moderately high FODMAP content (23 grams/day)

Intervention Type: OTHER

Diet low in FODMAPs

The subjects will obtain meal boxes prepared in the hospital kitchen with a low FODMAP content (\<5 grams/day)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adult patients with IBS according to Rome IV criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sahlgrenska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Magnus Simrén

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Magnus Simrén, Professor

Role: PRINCIPAL_INVESTIGATOR

Göteborg University

Locations

Magnus Simren

Gothenburg, Non-US/Non-Canadian, Sweden

Countries

Sweden

References

Algera JP, Demir D, Tornblom H, Nybacka S, Simren M, Storsrud S. Low FODMAP diet reduces gastrointestinal symptoms in irritable bowel syndrome and clinical response could be predicted by symptom severity: A randomized crossover trial. Clin Nutr. 2022 Dec;41(12):2792-2800. doi: 10.1016/j.clnu.2022.11.001. Epub 2022 Nov 4.

Reference Type: DERIVED

PMID: 36384081 (View on PubMed)

Other Identifiers

394-18

Identifier Type: -

Identifier Source: org_study_id