The Effect of Dietary Intervention on Symptoms, Epigenetics, and Gut Microbiota in IBS

Not Applicable

Completed

• Conditions: IBS - Irritable Bowel Syndrome
• Interventions: Other: Dietary intervention

• Registration Number: NCT03306381
• Lead Sponsor: Region Skane

Brief Summary

The aim of the present study is to research whether subjects with irritable bowel syndrome (IBS) display epigenetic/genetic changes or altered microbiota compared to a non-IBS control group. Further, we will investigate if these parameters as well as subjective IBS symptoms are affected by a 4-week long dietary intervention within the IBS patient group.

Detailed Description

The study will be performed on 140 subjects with verified IBS. Patients will be recruited from the clinic of Gastroenterology or Internal medicine as well as primary health care centers. At the start of the study patients will fill out protocols concerning Rom IV criteria (to validate that IBS criteria are filled) as well as IBS symptom rating scales. They will be examined by a physician/researcher who will complete protocols of clinical data. Blood and fecal samples will be collected. A control group of healthy, non-IBS individuals will go through the same procedure as described above.

Study participants with IBS will thereafter be randomized to receive an alternative diet resembling the FODMAP (Fermentable, Oligo-, Di-, Mono-saccharides And Polyols) diet (n=130), or to continue with their regular diet (control group; n=20). After 4 weeks of dietary intervention, there will be a follow-up where blood and fecal samples are once again collected. At this point in time, participants will also fill in IBS symptom rating scales again.

Samples from baseline and 4 weeks will be used for genetic/epigenetic (including genomic-wide association studies), gut microbiota and inflammatory parameter analyses.

Statistics

To study differences in the above-mentioned parameters between patients and controls as well as before and after dietary intervention, Mann-Whitney U-test and Wilcoxon test will be used, respectively.

Study Timeline

• Study First Submitted: 2017-09-18
• Study First Submitted QC: 2017-10-04
• Study First Posted: 2017-10-11
• Study Start: 2018-01-15
• Primary Completion: 2019-02-28
• Study Completion: 2019-02-28
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-09
• Last Update Posted: 2019-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• Verified IBS according to Rom IV criteria.

Exclusion Criteria

• Serious mental or somatic disease
• Abuse
• Inability to understand he Swedish language
• Already on a diet (e.g. vegan, FODMAP, gluten-free).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dietary intervention subject group	Dietary intervention	n=130. Participants on low FODMAP-similar diet during 4-week study period.

Primary Outcome Measures

Name	Time	Method
Genetic variation of enzymes regulating absorption of disaccharides	measured at baseline	Genetic expression of disaccharide-degradating enzymes will be measured at baseline and related to the response of study participants to dietary intervention.

Secondary Outcome Measures

Name	Time	Method
Irritable bowel syndrome-subjective severity scores (IBS-SSS) ratings	4 weeks	Changes from baseline in subjective symptoms according to the IBS-SSS.
Gut microbiota composition	4 weeks	Changes from baseline in fecal microbiota analysed by 16rs
Cytokines	4 weeks	Changes from baseline in cytokine plasma concentrations will be assessed by ELISA.
microRNA expression	4 weeks	Changes from baseline in microRNA expression will be assessed.
Visual analog scale for irritable bowel syndrome (VAS-IBS) ratings	4 weeks	Changes from baseline in subjective symptoms according to the VAS-IBS.

Trial Locations

Locations (1)

Deartment of INternal Medicine; 🇸🇪 Malmö, Sweden