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

Biruni University

Status: Completed

Conditions: Irritable Bowel Syndrome (IBS)

Treatments: Behavioral: Low-FODMAP Diet Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07619573

2015-KAEK-80-23-49/SKLOWFODMAP

Details and patient eligibility

About

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.

Full description

The low-FODMAP diet, developed for the treatment of IBS, is defined as a dietary regimen that restricts fermentable oligosaccharides, disaccharides, monosaccharides, and polyols-which are short-chain carbohydrates with limited or poor absorption.

Study Timeline and Interventions:

First Week: A 31-item "Data Collection Form" covering socio-demographic characteristics, health information, and nutritional habits will be administered.

Daily Monitoring: Daily records of the "Bristol Stool Scale" (BSS) will be maintained throughout the study.

Study Duration: The low-FODMAP diet intervention will be implemented for a total duration of 8 weeks.

Face-to-Face Assessments (Conducted at Baseline and Conclusion):

At the beginning and end of the study, the following assessments will be conducted face-to-face with the participants:

• 24-hour Dietary Recall
• Anthropometric measurements
• Frequency of FODMAP-sourced food consumption over the past month
• 7-item "International Physical Activity Questionnaire - Short Form" (IPAQ-SF)
• 5-item "IBS Symptom Severity Score" (IBS-SSS)
• 15-item "Gastrointestinal Symptom Rating Scale" (GSRS)
• 8-item "Epworth Sleepiness Scale" (ESS)

Laboratory Analysis:

Hs-CRP and fecal calprotectin levels will be analyzed from blood and stool samples collected at baseline and at the conclusion of the study.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged 18-65 years.
• Diagnosed with IBS according to the Rome IV criteria.

Exclusion criteria

• Use of antibiotics, NSAIDs, oral contraceptives, or hormone therapy during the study.
• Pregnancy or breastfeeding.
• Diagnosis of celiac disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Dietitian group

Experimental group

Description:

A dietitian planned the low FODMAP diet for the first group (n=31) through individual dietary counselling.

Treatment:

Behavioral: Low-FODMAP Diet Intervention

Doctor group

Active Comparator group

Description:

The second group (n=19) was given a brochure on the low FODMAP diet, as is routine in the hospital, listing foods prohibited by the gastroenterologist.

Treatment:

Behavioral: Low-FODMAP Diet Intervention