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

Study Overview
=================
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.

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Personalised diet based on microbiome analysis<br>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<br>* Personalized dietary intervention based on individual microbiome analysis<br>* Other names: Enbiosis IBS Scheme;|
| Active Comparator: Low FODMAP diet<br>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<br>* Low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols diet<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Microbiome, Microbiota, Personalised medicine, Artificial intelligence