Clinical Trial

EFFECT OF A DİETİTİAN-SUPERVİSED LOW-FODMAP DİET VERSUS STANDARD WRİTTEN ADVİCE ON GASTROİNTESTİNAL SYMPTOMS AND INFLAMMATORY BİOMARKERS İN IRRİTABLE BOWEL SYNDROME: A RANDOMİZED CONTROLLED TRİAL

Completed
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Summary
Background: Irritable Bowel Syndrome (IBS) is the most prevalent functional gastrointestinal (GI) pathology among GI disorders. Various dietary interventions, particularly the low-FODMAP diet, are employed to alleviate IBS symptoms. Study Population \& Design: This study will include 78 adult patients, aged 18-65, diagnosed with IBS according to Rome IV criteria at the Biruni University Faculty of Medicine Hospital Gastroenterology Outpatient Clinic. Participants will be divided into two parallel groups: Group 1 (n=39): Will receive dietary intervention solely through physician follow-up (provided with a standard hospital brochure listing prohibited foods). Group 2 (n=39): Will receive structured, personalized dietary intervention through individualized nutritional counseling by a dietitian. Duration: The low-FODMAP diet intervention for both groups will last for 8 weeks. Outcome Measures: At baseline (week 0) and at the conclusion of the study (week 8), the following assessments will be conducted: Clinical Scores: IBS Symptom Severity Score (IBS-SSS) and the 15-item Gastrointestinal Symptom Rating Scale (GSRS). Biomarkers: Hs-CRP and fecal calprotectin levels analyzed from blood and stool samples. Objective: The primary objective is to determine the impact of individualized nutritional counseling on GI symptoms and inflammatory biomarkers (hs-CRP, fecal calprotectin) during a low-FODMAP diet. Secondary objectives include evaluating the significance of the dietitian's role and observing how lifestyle factors (sleep and physical activity) influence symptom outcomes alongside nutritional therapy.
Trial Details
NCT Number NCT07619573
Lead Sponsor Biruni University
Conditions Irritable Bowel Syndrome (IBS)
Enrollment 50 participants
Start Date 2025-04-01
Primary Completion 2025-10-01 (estimated)
Study Completion 2025-10-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-02