Clinical Research Directory
Browse clinical research sites, groups, and studies.
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
Sponsor: Biruni University
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.
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2025-04-01
Completion Date
2025-10-30
Last Updated
2026-06-02
Healthy Volunteers
No
Conditions
Interventions
Low-FODMAP Diet Intervention
This intervention consists of an 8-week low-FODMAP dietary regimen aimed at restricting the intake of short-chain carbohydrates, including fermentable oligosaccharides, disaccharides, monosaccharides, and polyols. The intervention is administered through two distinct protocols to compare delivery methods: one group receives standard hospital care consisting of a brief physician follow-up accompanied by a standard educational brochure listing prohibited foods, while the other group receives structured, individualized nutritional counseling and personalized meal planning led by a professional dietitian.
Locations (2)
Biruni University Faculty of Medicine Hospital
Istanbul, Istanbul, Turkey (Türkiye)
Biruni University
Istanbul, Istanbul, Turkey (Türkiye)