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

Sponsor

Istanbul Medipol University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05646186

Collaborator

Bozyaka Training and Research Hospital (Other), Tepecik Training and Research Hospital (Other), Dr. Ersin Arslan Education and Training Hospital (Other)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Irritable Bowel Syndrome Irritable Bowel Syndrome With Diarrhea Irritable Bowel Syndrome With Constipation Irritable Bowel Syndrome Mixed	Dietary Supplement: Personalized dietary intervention based on microbiome analysis Dietary Supplement: Low-FODMAP diet	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

This is a double-blinded randomized controlled study. The participants will be blinded to the dietary interventions and the care providers will apply the diets that were allocated to them without knowing which diet they are applying. The investigators will not be able to obtain data until the data collection is finished.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Jan 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in IBS Symptom severity score [6 weeks]
Change in IBS Symptom severity score after 6 weeks of dietary intervention
Change in IBS quality of life scale [6 weeks]
Change in IBS quality of life scale 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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.