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

Irritable Bowel Syndrome Clinical Trial

Official title:

Comparison of Personalized Diet Implementation Based on Microbiome Analysis and FODMAP Diet Efficacy in Irritable Bowel Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05646186
• Other study ID #: E-10840098-772.02-5763
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

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

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