The Effects of FODMAPs in Patients With Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

— Sens-IBS  

Official title:

The Effects of Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols (FODMAPs) in Patients With Irritable Bowel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05182593
• Other study ID #: 394-18
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: September 1, 2020

Study information

• Verified date: January 2022
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 1, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Other:
• 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)
• Diet low in FODMAPs
The subjects will obtain meal boxes prepared in the hospital kitchen with a low FODMAP content (<5 grams/day)

Locations

Country	Name	City	State
Sweden	Magnus Simren	Gothenburg	Non-US/Non-Canadian

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Visceral Sensitivity and Bacterial Fermentation	Visceral Sensitivity and Bacterial Fermentation measured by the Lactulose Nutrient Challenge Test. To assess if visceral sensitivity and/or bacterial fermentation are predictors of clinical response to the low FODMAP diet or clinical worsening to the moderate/high FODMAP diet.	Baseline (day 0)
Other	Change in microbiota content of frozen fecal samples	Fecal microbiota analysis using 16 S RNA technique and Dysbiosis Test. Analyses will be done on samples from before and after both dietary periods.	Baseline (day 0), day 7, day 21, day 28
Other	Change in metabolites content	Frozen urine/serum/fecal samples will be analyzed in the future by gas/liquid chromatography mass spectrometry (metabolomics) analysis.Analyses will be done on samples from before and after both dietary periods.	Baseline (day 0), day 7, day 21, day 28
Primary	Change in Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) (7-10 days recall questionnaire)	Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) is a validated questionnaire that incorporates typical IBS symptoms such as abdominal pain, abdominal distension and bowel dysfunction, as well as quality of life. Subjects rated their symptoms on a visual analogue scale. The maximum achievable score is 500 points (sum of the 5 scales). A reduction in the total IBS-SSS score of at least 50 points is considered to indicate a clinically significant improvement in symptoms. The scale can also be used to classify IBS symptoms severity: <75 points (no symptoms), 75-175 points (mild symptoms), 175-300 points (moderate symptoms) and >300 points (severe symptoms). Measured after both dietary periods and at baseline of both periods.	Baseline (day 0), day 7, day 21, day 28
Primary	Change in Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) (modified, daily IBS-SSS)	Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) is a validated questionnaire that incorporates typical IBS symptoms such as abdominal pain, abdominal distension and bowel dysfunction, as well as quality of life. Subjects rated their symptoms on a visual analogue scale. The maximum achievable score is 500 points (sum of the 5 scales). A reduction in the total IBS-SSS score of at least 50 points is considered to indicate a clinically significant improvement in symptoms. The scale can also be used to classify IBS symptoms severity: <75 points (no symptoms), 75-175 points (mild symptoms), 175-300 points (moderate symptoms) and >300 points (severe symptoms). Measured after both dietary periods and at baseline of both periods.	Daily during day 7 to 14, and day 21 to 28
Primary	Change in Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome (GSRS-IBS)	Change in Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome (GSRS-IBS) measures symptom severity and symptom frequency in IBS patients and is a reliable and validated questionnaire. Thirteen questions are evaluated and rated from 1 (no discomfort at all) to 7 (very severe discomfort) on a Likert scale. The total scores can range from 13 to 91 (sum of the domains). The GSRS-IBS evaluates 5 domains: abdominal pain, bloating, constipation, diarrhea and satiety. Measured after both dietary periods and at baseline of both periods.	Baseline (day 0), day 7, day 21, day 28
Secondary	Change in stool consistency and frequency, measured by Bristol Stool Form (BSF)	Change in Bristol Stool Form, stool consistency/frequency per day after both dietary periods	Baseline (day 0), day 7, day 21, day 28
Secondary	Change in Hospital Anxiety and Depression Scale (HADS) score	The Hospital Anxiety and Depression Scale (HADS) contains 7 items for depression and 7 for anxiety. Each item is scored from 0 to 3, and therefore the total score per sub-scale can range from 0 to 21. When subjects score >10 on 1 or 2 of the sub-scales, clinically significant psychological distress (anxiety or depression) is likely present. Measured after both dietary periods and at baseline of both periods.	Baseline (day 0), day 7, day 21, day 28
Secondary	Change in Patient health questionnaire-15 (PHQ-15)	The (PHQ-15) is a validated questionnaire that evaluates 15 somatic symptoms and can be used as a screening tool for somatization in clinical research. The maximum score for men is 28 and 30 for women due to a question about menstrual problems. Measured after both dietary periods and at baseline of both periods.	Baseline (day 0), day 7, day 21, day 28
Secondary	Change in Visceral Sensitivity Index (VSI)	The Visceral Sensitivity Index (VSI) is a validated and reliable psychometric instrument which assesses gastrointestinal symptom-specific anxiety. The VSI contains 15 items that are scored from 0 to 5, therefore the total score can range from 0 to 75. Higher scores indicate more severe gastrointestinal symptom-specific anxiety. Measured after both dietary periods and at baseline of both periods.	Baseline (day 0), day 7, day 21, day 28