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

NCT ID: NCT03306381

Last Updated: 2019-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-15

Study Completion Date

2019-02-28

Brief Summary

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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

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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.

Conditions

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IBS - Irritable Bowel Syndrome

Keywords

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IBS Epigenetics Dietary intervention Gut Microbiota Inflammation Genetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Dietary intervention subject group

n=130. Participants on low FODMAP-similar diet during 4-week study period.

Group Type EXPERIMENTAL

Dietary intervention

Intervention Type OTHER

Elimination of certain products.

Control group

n=20. Participants on traditional IBS diet during 4-week study period.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dietary intervention

Elimination of certain products.

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Region Skane

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bodil Ohlsson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Region Skane

Locations

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Deartment of INternal Medicine

Malmo, , Sweden

Site Status

Countries

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Sweden

References

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Roth B, Ohlsson B. Overweight and vitamin D deficiency are common in patients with irritable bowel syndrome - a cross-sectional study. BMC Gastroenterol. 2024 Sep 3;24(1):296. doi: 10.1186/s12876-024-03373-x.

Reference Type DERIVED
PMID: 39227769 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35484927 (View on PubMed)

Other Identifiers

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IBS-2017

Identifier Type: -

Identifier Source: org_study_id