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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary intervention subject group | Experimental | n=130. Participants on low FODMAP-similar diet during 4-week study period. |
|
| Control group | No Intervention | n=20. Participants on traditional IBS diet during 4-week study period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary intervention | Other | Elimination of certain products. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | measured at baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Irritable bowel syndrome-subjective severity scores (IBS-SSS) ratings | Changes from baseline in subjective symptoms according to the IBS-SSS. | 4 weeks |
| Visual analog scale for irritable bowel syndrome (VAS-IBS) ratings |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bodil Ohlsson, MD, PhD | Region Skane | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deartment of INternal Medicine | Malmö | 20502 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39227769 | Derived | Roth B, Ohlsson B. Overweight and vitamin D deficiency are common in patients with irritable bowel syndrome - a cross-sectional study. BMC Gastroenterol. 2024 Sep 3;24(1):296. doi: 10.1186/s12876-024-03373-x. | |
| 35484927 | Derived | Nilholm C, Manoharan L, Roth B, D'Amato M, Ohlsson B. A starch- and sucrose-reduced dietary intervention in irritable bowel syndrome patients produced a shift in gut microbiota composition along with changes in phylum, genus, and amplicon sequence variant abundances, without affecting the micro-RNA levels. United European Gastroenterol J. 2022 May;10(4):363-375. doi: 10.1002/ueg2.12227. Epub 2022 Apr 28. |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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Changes from baseline in subjective symptoms according to the VAS-IBS.
| 4 weeks |
| Gut microbiota composition | Changes from baseline in fecal microbiota analysed by 16rs | 4 weeks |
| Cytokines | Changes from baseline in cytokine plasma concentrations will be assessed by ELISA. | 4 weeks |
| microRNA expression | Changes from baseline in microRNA expression will be assessed. | 4 weeks |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |