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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 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Dietitian group
A dietitian planned the low FODMAP diet for the first group (n=31) through individual dietary counselling.
Adfærdsmæssigt: 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
IBS-SSS
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Anthropometric measurement data
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Biruni University

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. april 2025

Primær færdiggørelse (Faktiske)

1. oktober 2025

Studieafslutning (Faktiske)

30. oktober 2025

Datoer for studieregistrering

Først indsendt

26. maj 2026

Først indsendt, der opfyldte QC-kriterier

26. maj 2026

Først opslået (Faktiske)

2. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2015-KAEK-80-23-49/SKLOWFODMAP

Plan for individuelle deltagerdata (IPD)

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