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

NCT05646186 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-12-12

No results posted yet for this study

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.

Conditions

  • Irritable Bowel Syndrome
  • Irritable Bowel Syndrome With Diarrhea
  • Irritable Bowel Syndrome With Constipation
  • Irritable Bowel Syndrome Mixed

Interventions

DIETARY_SUPPLEMENT

Personalized dietary intervention based on microbiome analysis

Personalized dietary intervention based on individual microbiome analysis

DIETARY_SUPPLEMENT

Low-FODMAP diet

Low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols diet

Sponsors & Collaborators

  • Bozyaka Training and Research Hospital

    collaborator OTHER

  • Tepecik Training and Research Hospital

    collaborator OTHER

  • Dr. Ersin Arslan Education and Training Hospital

    collaborator OTHER_GOV

  • Istanbul Medipol University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2023-01-30
Completion
2023-12-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05646186 on ClinicalTrials.gov