- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03306381
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Malmö, Sweden, 20502
- Deartment of INternal Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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)
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.
|
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
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.
|
measured at baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Irritable bowel syndrome-subjective severity scores (IBS-SSS) ratings
Time Frame: 4 weeks
|
Changes from baseline in subjective symptoms according to the IBS-SSS.
|
4 weeks
|
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.
|
4 weeks
|
Gut microbiota composition
Time Frame: 4 weeks
|
Changes from baseline in fecal microbiota analysed by 16rs
|
4 weeks
|
Cytokines
Time Frame: 4 weeks
|
Changes from baseline in cytokine plasma concentrations will be assessed by ELISA.
|
4 weeks
|
microRNA expression
Time Frame: 4 weeks
|
Changes from baseline in microRNA expression will be assessed.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bodil Ohlsson, MD, PhD, Region Skane
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IBS-2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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