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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05646186
Other study ID # E-10840098-772.02-5763
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date December 31, 2023

Study information

Verified date September 2022
Source Istanbul Medipol University Hospital
Contact Varol TUNALI, Dr.
Phone 00905556303231
Email varoltunali@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2023
Est. primary completion date January 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Personalized dietary intervention based on microbiome analysis
Personalized dietary intervention based on individual microbiome analysis
Low-FODMAP diet
Low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols diet

Locations

Country Name City State
Turkey Medipol University Bahcelievler Hospital Istanbul

Sponsors (4)

Lead Sponsor Collaborator
Istanbul Medipol University Hospital Bozyaka Training and Research Hospital, Dr. Ersin Arslan Education and Training Hospital, Tepecik Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in IBS Symptom severity score Change in IBS Symptom severity score after 6 weeks of dietary intervention 6 weeks
Primary Change in IBS quality of life scale Change in IBS quality of life scale after 6 weeks of dietary intervention 6 weeks
Primary Change in Anxiety-depression scale Change in Anxiety and depression scale after 6 weeks of dietary intervention 6 weeks
Secondary 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 6 months
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