Clinical trial NCT05646186: Personalized Dietary Intervention Based on Microbiome Analysis vs FODMAP Diet for Irritable Bowel Syndrome
Official title: Comparison of Personalized Diet Implementation Based on Microbiome Analysis and FODMAP Diet Efficacy in Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Irritable Bowel Syndrome
Irritable Bowel Syndrome With Diarrhea
Irritable Bowel Syndrome With Constipation
Irritable Bowel Syndrome Mixed
Keywords: Microbiome
Microbiota
Personalised medicine
Artificial intelligence
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
Collaborators: name: Bozyaka Training and Research Hospital
name: Tepecik Training and Research Hospital
name: Dr. Ersin Arslan Education and Training Hospital
First posted: 2022-12-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in IBS Symptom severity score
timeFrame: 6 weeks
measure: Change in IBS quality of life scale
timeFrame: 6 weeks
measure: Change in Anxiety-depression scale
timeFrame: 6 weeks
Secondary outcomes:
measure: Difference between study and control arms
timeFrame: 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Medipol University Bahcelievler Hospital
Study officials:
References: