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

Comparison of Personalized Diet Implementation Based on Microbiome Analysis and FODMAP Diet Efficacy in Irritable Bowel Syndrome

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.

Study Overview

• Status: Recruiting
• Conditions: Irritable Bowel Syndrome; Irritable Bowel Syndrome With Diarrhea; Irritable Bowel Syndrome With Constipation; Irritable Bowel Syndrome Mixed
• Intervention / Treatment: Dietary supplement: Personalized dietary intervention based on microbiome analysis; Dietary supplement: Low-FODMAP diet

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Varol TUNALI, Dr.; Phone Number: 00905556303231; Email: varoltunali@gmail.com

Study Locations

• Turkey
  • Istanbul, Turkey, 34196
    • Recruiting
    • Medipol University Bahcelievler Hospital
    • Contact: Osman Civil, MD; Phone Number: +905058334286; Email: dr.ocivil@hotmail.com
    • Sub-Investigator: Naciye Cigdem Arslan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Personalized dietary intervention based on microbiome analysis; Personalized dietary intervention based on individual microbiome analysis; Other Names: Enbiosis IBS Scheme
Active Comparator: 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.	Dietary supplement: Low-FODMAP diet; Low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital
• Collaborators: Tepecik Training and Research Hospital; Bozyaka Training and Research Hospital; Dr. Ersin Arslan Education and Training Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Anticipated): January 30, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: October 6, 2022
• First Submitted That Met QC Criteria: December 2, 2022
• First Posted (Estimate): December 12, 2022

Study Record Updates

• Last Update Posted (Estimate): December 12, 2022
• Last Update Submitted That Met QC Criteria: December 2, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Microbiome; Microbiota; Artificial intelligence; Personalised medicine
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Diarrhea; Constipation
• Other Study ID Numbers: E-10840098-772.02-5763

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Individual participant data will be made available in a data repository

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No