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Irritable Bowel Syndrome is a common disease to which there is no curable treatment. Diet is considered to trigger symptoms associated with the clinical picture of IBS, and dietary treatment is thus believed to relieve the symptoms of IBS. As the disease is very heterogeneous in its manifestation, different treatment options might be indicated depending on the predominant symptom. To investigate the response to different dietary treatment options, a randomized controlled intervention trial will be carried out in adult patients (>18 y) with IBS according to Rome IV criteria. The aim of this study is to compare the response to two different dietary treatments or optimized medical treatment.
The study is a randomized controlled trial comparing three different treatments during four weeks:
Combination of low FODMAP diet + traditional dietary advice (based on NICE recommendations)
Diet low in carbohydrates
Optimized pharmacological tretament based on predominant symptom and previous experience with pharmacological treatmment.
Pain/discomfort:
Constipation:
Primary endpoint: IBS-SSS reduction >50 points
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet A | Experimental | Low carbohydrate diet |
|
| Medical treatment | Active Comparator | Optimized Medical treatment |
|
| Diet B | Experimental | Traditional dietary advice and low FODMAP content |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional dietary advice and low FODMAP content | Other | Traditional dietary advice according to the Brittish Dietetic Association including reducing the intake of fermentable carbohydrates. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion (%) of patients who respond to treatment | A responder is defined as having an IBS-SSS reduction >50 points @ 4 weeks | Baseline to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in symptom severity | Absolute and percentage change in IBS-SSS | Baseline, 4 weeks, 3 and 6 months |
| Determinants for GI symptoms by IBS-SSS | GI symptoms measured by IBS-SSS |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative assessment | Patient's subjective experiences related to the dietary intervention described by qualitative methods. | Approx. at 3 months follow-up |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magnus Simren | Gothenburg | Non-US/Non-Canadian | 44331 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38643782 | Derived | Nybacka S, Tornblom H, Josefsson A, Hreinsson JP, Bohn L, Frandemark A, Weznaver C, Storsrud S, Simren M. A low FODMAP diet plus traditional dietary advice versus a low-carbohydrate diet versus pharmacological treatment in irritable bowel syndrome (CARIBS): a single-centre, single-blind, randomised controlled trial. Lancet Gastroenterol Hepatol. 2024 Jun;9(6):507-520. doi: 10.1016/S2468-1253(24)00045-1. Epub 2024 Apr 18. | |
| 35037893 |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| Low carbohydrate diet | Other | Diet that contains a maximum of 10 energy percent of carbohydrates, 23 energy % proteins and 67 energy % fat. |
|
| Optimized Medical treatment | Other | Standard consultation by physician and if needed patients will receive medical treatment based on the most prominent symptom. Constipation: osmotic laxatives, linaclotide. Diarrhea: loperamid, bile acid binders. Pain: anti depressent, antispasmodics, linaclotide. |
|
| Baseline, 4 weeks, 3 and 6 months |
| Determinants for GI symptoms by GSRS-IBS | GI symptoms measured by GSRS-IBS | Baseline, 4 weeks, 3 and 6 months |
| Predictors of response to treatment | Potential predictors include demographics, questionnaire data, microbiota, metabolites, immunology | Baseline to 4 weeks |
| Adherence to allocated intervention | Including compliance to dietary intervention during 4 weeks, and long-term adherence during follow-up | Baseline, 4 weeks, 3 and 6 months |
| Change in microbiota content | Fecal microbiota analysis using 16S technique | Baseline, 4 weeks, 6 months |
| Change in extra-intestinal symptoms and quality of life | As assessed by IBS specific questionnaires | Baseline, 4 weeks, 3 and 6 months |
| Change in metabolic profile | Metabolomics in serum and urine samples | Baseline, 4 weeks, 6 months |
| Derived |
| Nybacka S, Tornblom H, Simren M, Storsrud S. The Role of Carbohydrates in Irritable Bowel Syndrome: Protocol for a Randomized Controlled Trial Comparing Three Different Treatment Options. JMIR Res Protoc. 2022 Jan 17;11(1):e31413. doi: 10.2196/31413. |
| 34560607 | Derived | Algera JP, Storsrud S, Lindstrom A, Simren M, Tornblom H. Gluten and fructan intake and their associations with gastrointestinal symptoms in irritable bowel syndrome: A food diary study. Clin Nutr. 2021 Oct;40(10):5365-5372. doi: 10.1016/j.clnu.2021.09.002. Epub 2021 Sep 9. |
| D004066 | Digestive System Diseases |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |