The Effect of Dietary Intervention on Symptoms, Epigenetics, and Gut Microbiota in IBS
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|ClinicalTrials.gov Identifier: NCT03306381|
Recruitment Status : Completed
First Posted : October 11, 2017
Last Update Posted : December 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|IBS - Irritable Bowel Syndrome||Other: Dietary intervention||Not Applicable|
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.
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 (Clinical Trial)|
|Actual Enrollment :||105 participants|
|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|
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.
- 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.
- Irritable bowel syndrome-subjective severity scores (IBS-SSS) ratings [ Time Frame: 4 weeks ]Changes from baseline in subjective symptoms according to the IBS-SSS.
- 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.
- Gut microbiota composition [ Time Frame: 4 weeks ]Changes from baseline in fecal microbiota analysed by 16rs
- Cytokines [ Time Frame: 4 weeks ]Changes from baseline in cytokine plasma concentrations will be assessed by ELISA.
- microRNA expression [ Time Frame: 4 weeks ]Changes from baseline in microRNA expression will be assessed.
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
|Deartment of INternal Medicine|
|Malmö, Sweden, 20502|
|Principal Investigator:||Bodil Ohlsson, MD, PhD||Region Skane|