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
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Istanbul
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Istanbul, Istanbul, Turquía (Türkiye)
- Biruni University Faculty of Medicine Hospital
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Istanbul, Istanbul, Turquía (Türkiye)
- Biruni University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Dietitian group
A dietitian planned the low FODMAP diet for the first group (n=31) through individual dietary counselling.
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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. |
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Comparador activo: 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.
|
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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IBS-SSS
Periodo de tiempo: 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.
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From enrollment to the end of treatment at 8 weeks
|
|
GSRS
Periodo de tiempo: 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.
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From enrollment to the end of treatment at 8 weeks
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Fecal Calprotectin
Periodo de tiempo: From enrollment to the end of treatment at 8 weeks
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Fecal calprotectin levels will be analyzed from stool samples collected from participants to evaluate gastrointestinal inflammation.
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From enrollment to the end of treatment at 8 weeks
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Hs-CRP
Periodo de tiempo: From enrollment to the end of treatment at 8 weeks
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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.
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From enrollment to the end of treatment at 8 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Anthropometric measurement data
Periodo de tiempo: 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
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From enrollment to the end of treatment at 8 weeks
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IPAQ-SF
Periodo de tiempo: 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
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From enrollment to the end of treatment at 8 weeks
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Epworth Sleepiness Scale (ESS)
Periodo de tiempo: From enrollment to the end of treatment at 8 weeks
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The ESS is an eight-item self-report measure that assesses an individual's likelihood of falling asleep in various everyday situations
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From enrollment to the end of treatment at 8 weeks
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Data Collection Form
Periodo de tiempo: At the beginning of the study
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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.
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At the beginning of the study
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Daily Total FODMAP Intake
Periodo de tiempo: From enrollment to the end of treatment at 8 weeks
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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.
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From enrollment to the end of treatment at 8 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Sevde KAHRAMAN, Asst. Prof., Biruni University
- Director de estudio: Zeynep Çavdar, Master's student and dietitan, Biruni University
- Investigador principal: Koray Koçhan, Specialist of Gastroenterology, Department of Gastroenterology, Biruni University Faculty of Medicine Hospital
- Investigador principal: Huri Demirci, PhD, Associate Professor, Biruni University
- Silla de estudio: Fatma Çelik, PhD, Professor, Biruni University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2015-KAEK-80-23-49/SKLOWFODMAP
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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