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

Istanbul Medipol University Hospital100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

100

Conditions

Irritable Bowel Syndrome Irritable Bowel Syndrome With Diarrhea

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in IBS Symptom severity score

Change in IBS Symptom severity score after 6 weeks of dietary intervention

Time frame: 6 weeks

Change in IBS quality of life scale

Change in IBS quality of life scale after 6 weeks of dietary intervention

Time frame: 6 weeks

Change in Anxiety-depression scale

Change in Anxiety and depression scale after 6 weeks of dietary intervention

Time frame: 6 weeks

Secondary Outcomes

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

Time frame: 6 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts