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

The Effect of Dietary Intervention on Symptoms in Relation to Genetical Characteristics, Epigenetics, Gut Microbiota, and Autoantibodies in IBS Patients

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.

Study Overview

• Status: Completed
• Conditions: IBS - Irritable Bowel Syndrome
• Intervention / Treatment: Other: Dietary intervention

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 Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Malmö, Sweden, 20502
    • Deartment of INternal Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dietary intervention subject group; n=130. Participants on low FODMAP-similar diet during 4-week study period.	Other: Dietary intervention; Elimination of certain products.
No Intervention: Control group; n=20. Participants on traditional IBS diet during 4-week study period.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Region Skane
• Investigators: Principal Investigator: Bodil Ohlsson, MD, PhD, Region Skane

Publications and helpful links

General Publications

• Nilholm C, Manoharan L, Roth B, D'Amato M, Ohlsson B. A starch- and sucrose-reduced dietary intervention in irritable bowel syndrome patients produced a shift in gut microbiota composition along with changes in phylum, genus, and amplicon sequence variant abundances, without affecting the micro-RNA levels. United European Gastroenterol J. 2022 May;10(4):363-375. doi: 10.1002/ueg2.12227. Epub 2022 Apr 28.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2018
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): February 28, 2019

Study Registration Dates

• First Submitted: September 18, 2017
• First Submitted That Met QC Criteria: October 4, 2017
• First Posted (Actual): October 11, 2017

Study Record Updates

• Last Update Posted (Actual): December 10, 2019
• Last Update Submitted That Met QC Criteria: December 9, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Genetics; Inflammation; IBS; Epigenetics; Gut Microbiota; Dietary intervention
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Irritable Bowel Syndrome
• Other Study ID Numbers: IBS-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No