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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
105
Elimination of certain products.
Deartment of INternal Medicine
Malmö, Sweden
Genetic variation of enzymes regulating absorption of disaccharides
Genetic expression of disaccharide-degradating enzymes will be measured at baseline and related to the response of study participants to dietary intervention.
Time frame: measured at baseline
Irritable bowel syndrome-subjective severity scores (IBS-SSS) ratings
Changes from baseline in subjective symptoms according to the IBS-SSS.
Time frame: 4 weeks
Visual analog scale for irritable bowel syndrome (VAS-IBS) ratings
Changes from baseline in subjective symptoms according to the VAS-IBS.
Time frame: 4 weeks
Gut microbiota composition
Changes from baseline in fecal microbiota analysed by 16rs
Time frame: 4 weeks
Cytokines
Changes from baseline in cytokine plasma concentrations will be assessed by ELISA.
Time frame: 4 weeks
microRNA expression
Changes from baseline in microRNA expression will be assessed.
Time frame: 4 weeks
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