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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03306381
Recruitment Status : Completed
First Posted : October 11, 2017
Last Update Posted : December 10, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
IBS - Irritable Bowel Syndrome Other: Dietary intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effect of Dietary Intervention on Symptoms in Relation to Genetical Characteristics, Epigenetics, Gut Microbiota, and Autoantibodies in IBS Patients
Actual Study Start Date : January 15, 2018
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : February 28, 2019

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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03306381


Locations
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Sweden
Deartment of INternal Medicine
Malmö, Sweden, 20502
Sponsors and Collaborators
Region Skane
Investigators
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Principal Investigator: Bodil Ohlsson, MD, PhD Region Skane
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT03306381    
Other Study ID Numbers: IBS-2017
First Posted: October 11, 2017    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Region Skane:
IBS
Epigenetics
Dietary intervention
Gut Microbiota
Inflammation
Genetics
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases