Personalized Dietary Intervention Based on Microbiome Analysis vs FODMAP Diet for Irritable Bowel Syndrome
NCT ID: NCT05646186
Last Updated: 2022-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2022-10-01
2023-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Personalised diet based on microbiome analysis
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.
Personalized dietary intervention based on microbiome analysis
Personalized dietary intervention based on individual microbiome analysis
Low FODMAP diet
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.
Low-FODMAP diet
Low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols diet
Interventions
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Personalized dietary intervention based on microbiome analysis
Personalized dietary intervention based on individual microbiome analysis
Low-FODMAP diet
Low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols diet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* To be diagnosed with IBS (IBS-D, IBS-C, IBS-M) according to the Rome IV Criteria
* To give consent to participate in the study voluntarily
* Being a smartphone and/or internet user (for dietitian follow-up and clinical follow-up)
Exclusion Criteria
* Having another known diagnosis of gastrointestinal disease (inflammatory bowel disease, malabsorption of any macronutrient, intestinal resection, celiac disease, etc.)
* Colonoscopy history (in the last 1 year)
* History of abdominal surgery other than appendectomy or hysterectomy
* Psychiatric comorbidity
* Chronic diseases that will affect the microbiome (cancer, diabetes, cardiovascular disease, liver diseases, neurological diseases, etc.)
* Use of drugs that may affect digestive function in the 4 weeks prior to the study (antibiotics (including use in the last 4 weeks), probiotics, narcotic analgesics, lactulose (prebiotics))
* Patients taking dietary supplements
* Excluded from the study if following a restricted diet.
18 Years
65 Years
ALL
No
Sponsors
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Bozyaka Training and Research Hospital
OTHER
Tepecik Training and Research Hospital
OTHER
Dr. Ersin Arslan Education and Training Hospital
OTHER_GOV
Istanbul Medipol University Hospital
OTHER
Responsible Party
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Locations
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Medipol University Bahcelievler Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Osman Civil, MD
Role: primary
References
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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.
Other Identifiers
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E-10840098-772.02-5763
Identifier Type: -
Identifier Source: org_study_id