Irritable Bowel Syndrome, Irritable Bowel Syndrome Mixed, Irritable Bowel Syndrome With Constipation, Irritable Bowel Syndrome With Diarrhea
Conditions
Keywords
Microbiome, Microbiota, Personalised medicine, Artificial intelligence
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.
Interventions
DIETARY_SUPPLEMENTPersonalized dietary intervention based on microbiome analysis
Personalized dietary intervention based on individual microbiome analysis
DIETARY_SUPPLEMENTLow-FODMAP diet
Low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols diet
Sponsors
Bozyaka Training and Research Hospital
Tepecik Training and Research Hospital
Dr. Ersin Arslan Education and Training Hospital
Istanbul Medipol University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Turkey (Türkiye)
Contacts
Primary ContactVarol TUNALI, Dr.
Outcome results
None listed