An interventional study of Dietary intervention in IBS - Irritable Bowel Syndrome, sponsored by Region Skane. Completed at 1 site in Sweden. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-10.
Sponsored by Region Skane · Not applicable, Interventional, and Basic science
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.
1,116 studies on the registry are indexed under Irritable Bowel Syndrome; 208 are open to participants now.
This study's enrollment of 105 is above the median of 70 across 896 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Region Skane is the lead sponsor of 386 studies on the registry; 122 are open to participants now.
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Exclusion Criteria:
n=130. Participants on low FODMAP-similar diet during 4-week study period.
Other: Dietary intervention
n=20. Participants on traditional IBS diet during 4-week study period.
Elimination of certain products.
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
Plan to share: No
Ran from Jan 2018 to primary completion in Feb 2019, 13 months.
Of 305 non-industry interventional studies with no phase under Irritable Bowel Syndrome, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 40. This study's 13 months is below that.
Counting every sponsor, half of 357 studies reached it within 19 months; a quarter within 9 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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