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NCT05646186
Personalized Dietary Intervention Based on Microbiome Analysis vs FODMAP Diet for Irritable Bowel Syndrome
Conditions: Irritable Bowel Syndrome, Irritable Bowel Syndrome With Diarrhea, Irritable Bowel Syndrome With Constipation, Irritable Bowel Syndrome Mixed
Sex: All
Ages: 18 Years – 65 Years
Phase: NA
Enrollment: 100
Sponsor: Istanbul Medipol University Hospital
Location: Turkey
Summary
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.
Eligibility Criteria
Inclusion Criteria:To be between the ages of 18-65To be diagnosed with IBS (IBS-D, IBS-C, IBS-M) according to the Rome IV CriteriaTo give consent to participate in the study voluntarilyBeing a smartphone and/or internet user (for dietitian follow-up and clinical follow-up)Not meeting any of the exclusion criteriaExclusion Criteria:Pregnant or planning to become pregnantHaving 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 hysterectomyPsychiatric comorbidityChronic 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 supplementsExcluded from the study if following a restricted diet.
Source: ClinicalTrials.gov (NCT05646186). StuddyBuddy aggregates publicly available trial information.