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

Medipol Health Group

Status: Enrolling

Conditions: Irritable Bowel Syndrome; Irritable Bowel Syndrome With Constipation; Irritable Bowel Syndrome With Diarrhea; Irritable Bowel Syndrome Mixed

Treatments: Dietary Supplement: Personalized dietary intervention based on microbiome analysis; Dietary Supplement: Low-FODMAP diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05646186

E-10840098-772.02-5763

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Personalised diet based on microbiome analysis

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Personalized dietary intervention based on microbiome analysis

Low FODMAP diet

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Low-FODMAP diet