The Effects of FODMAPs in Patients With Irritable Bowel Syndrome (Sens-IBS)

Sahlgrenska University Hospital

Status: Completed

Conditions: Irritable Bowel Syndrome

Treatments: Other: Diet low in FODMAPs; Other: Diet moderate/high in FODMAPs

Study type: Interventional

Funder types: Other

Identifiers

NCT05182593

394-18

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Other: Diet moderate/high in FODMAPs

Other: Diet low in FODMAPs

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

Experimental group

Description:

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.

Treatment:

Other: Diet moderate/high in FODMAPs

Other: Diet low in FODMAPs