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Completed

NCT Number: NCT03306381

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Deartment of INternal Medicine

Malmö, 20502, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Dietary Intervention

Other

Elimination of certain products.

Primary outcomes

  1. Genetic variation of enzymes regulating absorption of disaccharides

    Time frame: 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 outcomes

  1. Irritable bowel syndrome-subjective severity scores (IBS-SSS) ratings

    Time frame: 4 weeks

    Changes from baseline in subjective symptoms according to the IBS-SSS.

  2. Visual analog scale for irritable bowel syndrome (VAS-IBS) ratings

    Time frame: 4 weeks

    Changes from baseline in subjective symptoms according to the VAS-IBS.

  3. Gut microbiota composition

    Time frame: 4 weeks

    Changes from baseline in fecal microbiota analysed by 16rs

  4. Cytokines

    Time frame: 4 weeks

    Changes from baseline in cytokine plasma concentrations will be assessed by ELISA.

  5. microRNA expression

    Time frame: 4 weeks

    Changes from baseline in microRNA expression will be assessed.

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 11, 2017
Registry last updated
Dec 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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