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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. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

50

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Türkei (türkiye)
    • Istanbul
      • Istanbul, Istanbul, Türkei (türkiye)
        • Biruni University Faculty of Medicine Hospital
      • Istanbul, Istanbul, Türkei (türkiye)
        • Biruni University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Dietitian group
A dietitian planned the low FODMAP diet for the first group (n=31) through individual dietary counselling.
Verhalten: 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.
Aktiver 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.
Verhalten: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
IBS-SSS
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Anthropometric measurement data
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Biruni University

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. April 2025

Primärer Abschluss (Tatsächlich)

1. Oktober 2025

Studienabschluss (Tatsächlich)

30. Oktober 2025

Studienanmeldedaten

Zuerst eingereicht

26. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. Mai 2026

Zuerst gepostet (Tatsächlich)

2. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

2. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

26. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2015-KAEK-80-23-49/SKLOWFODMAP

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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