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

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.

Conditions

• Irritable Bowel Syndrome (IBS)

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

• Biruni University

  lead OTHER

Principal Investigators

• Sevde KAHRAMAN, Asst. Prof. · Biruni University

• Zeynep Çavdar, Master's student and dietitan · Biruni University

• Koray Koçhan, Specialist of Gastroenterology · Department of Gastroenterology, Biruni University Faculty of Medicine Hospital

• Huri Demirci, PhD, Associate Professor · Biruni University

• Fatma Çelik, PhD, Professor · Biruni University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-01

Primary Completion

2025-10-01

Completion

2025-10-30

Countries

• Turkey (Türkiye)

Study Locations