Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

26 maj 2026 uppdaterad av: Sevde Kahraman, Biruni University

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

50

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Turkiet (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turkiet (Türkiye)
        • Biruni University Faculty of Medicine Hospital
      • Istanbul, Istanbul, Turkiet (Türkiye)
        • Biruni University

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Dietitian group
A dietitian planned the low FODMAP diet for the first group (n=31) through individual dietary counselling.
Beteende: 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.
Aktiv komparator: Doctor group
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.
Beteende: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
IBS-SSS
Tidsram: From enrollment to the end of treatment at 8 weeks
Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS). The IBS-SSS consists of 5 questions, each scored from 0 to 100, with a maximum possible total score of 500. It determines the severity of abdominal pain, abdominal pain frequency, abdominal bloating severity, satisfaction with bowel habits, and the impact of the disease on quality of life. Total scores are classified as follows: 75-174 points = mild IBS, 175-299 points = moderate IBS, and greater than or equal to 300 points = severe IBS. Higher scores indicate more severe IBS symptoms.
From enrollment to the end of treatment at 8 weeks
GSRS
Tidsram: From enrollment to the end of treatment at 8 weeks
Gastrointestinal Symptom Rating Scale (GSRS). The GSRS is a 15-item questionnaire that uses a 5-point Likert scale to assess the severity of gastrointestinal symptoms across 5 subscales: abdominal pain, reflux, diarrhoea, indigestion, and constipation. Scores are aggregated to determine symptom severity, where higher scores represent a higher severity of gastrointestinal symptoms.
From enrollment to the end of treatment at 8 weeks
Fecal Calprotectin
Tidsram: From enrollment to the end of treatment at 8 weeks
Fecal calprotectin levels will be analyzed from stool samples collected from participants to evaluate gastrointestinal inflammation.
From enrollment to the end of treatment at 8 weeks
Hs-CRP
Tidsram: From enrollment to the end of treatment at 8 weeks
High-Sensitivity C-Reactive Protein (hs-CRP). Hs-CRP levels will be analyzed from blood samples collected from individuals to monitor systemic biochemical findings of inflammation.
From enrollment to the end of treatment at 8 weeks

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Anthropometric measurement data
Tidsram: From enrollment to the end of treatment at 8 weeks
height in cm, body weight in kg, waist circumference in cm, hip circumference in cm, body composition and bioelectrical impedance analysis (BIA) measurements
From enrollment to the end of treatment at 8 weeks
IPAQ-SF
Tidsram: From enrollment to the end of treatment at 8 weeks
The IPAQ-SF is a seven-item measure that assesses individuals' physical activity levels over the past seven days. The scale inquires about walking, moderate and vigorous physical activities, and time spent sitting, and physical activity level is calculated in MET-minutes per week
From enrollment to the end of treatment at 8 weeks
Epworth Sleepiness Scale (ESS)
Tidsram: From enrollment to the end of treatment at 8 weeks
The ESS is an eight-item self-report measure that assesses an individual's likelihood of falling asleep in various everyday situations
From enrollment to the end of treatment at 8 weeks
Data Collection Form
Tidsram: At the beginning of the study
At the beginning of the study, a 31-item Data Collection Form; covering the sociodemographic characteristics, health information and dietary habits of participating patients was administered.
At the beginning of the study
Daily Total FODMAP Intake
Tidsram: From enrollment to the end of treatment at 8 weeks
Food consumption records were taken for 3 days before and after the diet. The data was entered into the Bebis program. Food consumption records were calculated using the Nutrition Information System (BeBiS, version 9, Germany) for energy, macronutrients, micronutrients and FODMAP amounts (total FODMAP (g) = lactose (g) + oligosaccharides (g) + mannitol (g) + sorbitol (g)). Free fructose, a monosaccharide, could not be included in this programme as it could not be calculated.
From enrollment to the end of treatment at 8 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Biruni University

Utredare

  • Studiestol: Sevde KAHRAMAN, Asst. Prof., Biruni University
  • Studierektor: Zeynep Çavdar, Master's student and dietitan, Biruni University
  • Huvudutredare: Koray Koçhan, Specialist of Gastroenterology, Department of Gastroenterology, Biruni University Faculty of Medicine Hospital
  • Huvudutredare: Huri Demirci, PhD, Associate Professor, Biruni University
  • Studiestol: Fatma Çelik, PhD, Professor, Biruni University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 april 2025

Primärt slutförande (Faktisk)

1 oktober 2025

Avslutad studie (Faktisk)

30 oktober 2025

Studieregistreringsdatum

Först inskickad

26 maj 2026

Först inskickad som uppfyllde QC-kriterierna

26 maj 2026

Första postat (Faktisk)

2 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

2 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

26 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2015-KAEK-80-23-49/SKLOWFODMAP

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera