Clinical trial NCT05182593: The Effects of FODMAPs in Patients With Irritable Bowel Syndrome
Official title: The Effects of Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols (FODMAPs) in Patients With Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: FODMAPs
carbohydrates
gastrointestinal symptoms
IBS
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2022-01-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, Double-blind, Cross-over Trial
Primary purpose: SUPPORTIVE_CARE

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).

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

Primary outcomes:
measure: Change in Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) (7-10 days recall questionnaire)
timeFrame: Baseline (day 0), day 7, day 21, day 28
measure: Change in Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) (modified, daily IBS-SSS)
timeFrame: Daily during day 7 to 14, and day 21 to 28
measure: Change in Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome (GSRS-IBS)
timeFrame: Baseline (day 0), day 7, day 21, day 28
Secondary outcomes:
measure: Change in stool consistency and frequency, measured by Bristol Stool Form (BSF)
timeFrame: Baseline (day 0), day 7, day 21, day 28
measure: Change in Hospital Anxiety and Depression Scale (HADS) score
timeFrame: Baseline (day 0), day 7, day 21, day 28
measure: Change in Patient health questionnaire-15 (PHQ-15)
timeFrame: Baseline (day 0), day 7, day 21, day 28
measure: Change in Visceral Sensitivity Index (VSI)
timeFrame: Baseline (day 0), day 7, day 21, day 28
Other outcomes:
measure: Visceral Sensitivity and Bacterial Fermentation
timeFrame: Baseline (day 0)
measure: Change in microbiota content of frozen fecal samples
timeFrame: Baseline (day 0), day 7, day 21, day 28
measure: Change in metabolites content
timeFrame: Baseline (day 0), day 7, day 21, day 28
Locations:
city: Gothenburg
country: Sweden
facility: Magnus Simren
state: Non-US/Non-Canadian
Study officials:
affiliation: Göteborg University
name: Magnus Simrén, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.