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| Name | Class |
|---|---|
| Bozyaka Training and Research Hospital | OTHER |
| Tepecik Training and Research Hospital | OTHER |
| Dr. Ersin Arslan Education and Training Hospital | OTHER_GOV |
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irritable bowel syndrome (IBS) is a well-known risk factor for diseases of the anal region (hemorrhoids, anal fissures, etc.) and large intestine (colon cancer, diverticular disease). Untreatable IBS disease not only impairs the patient's quality of life but also reduces the success of surgical treatment in these diseases.
Today, only one-third of IBS patients achieve successful results with the treatment methods and diets used routinely. Balancing the composition of the gut microbiota may yield satisfactory results in this patient group. With the results of our study, we aim to reveal the effect of microbiome analysis and personalized diet on symptoms and its place in treatment in patients with IBS disease.
Patients applying to Gastroenterology outpatient clinics in respective centers due to IBS will be randomized into two groups. The patients in the control group will follow the FODMAP diet protocol for IBS; In the study group, a personalized diet will be applied according to the gut microbiota. No nutritional supplements will be used in either group. Changes in defecation habits and quality of life scale of both groups will be evaluated at the end of 6 weeks and the results will be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalised diet based on microbiome analysis | Experimental | Personalized diet application based on artificial intelligence-assisted microbiome analysis. After the microbiome analysis is made from the stool samples to be taken from the individuals, a personalized diet program will be created with an artificial intelligence-based algorithm and a diet will be applied for 6 weeks with the support of a professional dietitian. |
|
| Low FODMAP diet | Active Comparator | After the microbiome analysis is made from the stool samples to be taken from the individuals, low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) diet will be applied for 6 weeks with the support of a professional dietitian. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized dietary intervention based on microbiome analysis | Dietary Supplement | Personalized dietary intervention based on individual microbiome analysis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in IBS Symptom severity score | Change in IBS Symptom severity score after 6 weeks of dietary intervention | 6 weeks |
| Change in IBS quality of life scale | Change in IBS quality of life scale after 6 weeks of dietary intervention | 6 weeks |
| Change in Anxiety-depression scale | Change in Anxiety and depression scale after 6 weeks of dietary intervention | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between study and control arms | A statistically significant difference between study and control groups based on the IBS-SSS, IBS-QOL and Anxiety depression scale | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Varol TUNALI, Dr. | Contact | 00905556303231 | varoltunali@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medipol University Bahcelievler Hospital | Recruiting | Istanbul | 34196 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38717025 | Derived | Tunali V, Arslan NC, Ermis BH, Dervis Hakim G, Gundogdu A, Hora M, Nalbantoglu OU. A Multicenter Randomized Controlled Trial of Microbiome-Based Artificial Intelligence-Assisted Personalized Diet vs Low-Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols Diet: A Novel Approach for the Management of Irritable Bowel Syndrome. Am J Gastroenterol. 2024 Sep 1;119(9):1901-1912. doi: 10.14309/ajg.0000000000002862. Epub 2024 May 8. |
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Individual participant data will be made available in a data repository
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This is a double-blinded randomized controlled study. The participants will be blinded to the dietary interventions and the care providers will apply the diets that were allocated to them without knowing which diet they are applying. The investigators will not be able to obtain data until the data collection is finished.
|
| Low-FODMAP diet | Dietary Supplement | Low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols diet |
|
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000092622 | FODMAP Diet |
| ID | Term |
|---|---|
| D000092724 | Elimination Diets |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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