Personalized Dietary Intervention Based on Microbiome Analysis vs FODMAP Diet for Irritable Bowel Syndrome

Not Applicable

Recruiting

• Conditions: Irritable Bowel Syndrome With Constipation; Irritable Bowel Syndrome; Irritable Bowel Syndrome With Diarrhea; Irritable Bowel Syndrome Mixed
• Interventions: Dietary Supplement: Personalized dietary intervention based on microbiome analysis; Dietary Supplement: Low-FODMAP diet

• Registration Number: NCT05646186
• Lead Sponsor: Istanbul Medipol University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-09
• Study Start: 2022-10-01
• Study First Submitted: 2022-10-06
• Study First Submitted QC: 2022-12-02
• Last Update Submitted: 2022-12-02
• Study First Posted: 2022-12-12
• Last Update Posted: 2022-12-12
• Primary Completion: 2023-01-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• To be between the ages of 18-65
• 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)
• Not meeting any of the exclusion criteria

Exclusion Criteria

• Pregnant or planning to become pregnant
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Personalised diet based on microbiome analysis	Personalized dietary intervention 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.
Low FODMAP diet	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.

Primary Outcome Measures

Name	Time	Method
Change in IBS quality of life scale	6 weeks	Change in IBS quality of life scale after 6 weeks of dietary intervention
Change in IBS Symptom severity score	6 weeks	Change in IBS Symptom severity score after 6 weeks of dietary intervention
Change in Anxiety-depression scale	6 weeks	Change in Anxiety and depression scale after 6 weeks of dietary intervention

Secondary Outcome Measures

Name	Time	Method
Difference between study and control arms	6 months	A statistically significant difference between study and control groups based on the IBS-SSS, IBS-QOL and Anxiety depression scale

Trial Locations

Locations (1)

Medipol University Bahcelievler Hospital; 🇹🇷 Istanbul, Turkey