Irritable Bowel Syndrome (IBS)
Conditions
Keywords
Irritable Bowel Syndrome (IBS), low-FODMAP diet, gastrointestinal symptoms, dietitian
Brief summary
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.
Detailed 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.
Interventions
BEHAVIORALLow-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.
Sponsors
Biruni University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The patients were randomly assigned to two groups: One group (n=31) followed a low FODMAP diet under the guidance of a dietitian, while the other group (n=19) followed the diet based on a brochure provided by a doctor.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IBS-SSS | 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. |
| GSRS | 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. |
| Fecal Calprotectin | 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. |
| Hs-CRP | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anthropometric measurement data | 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 |
| IPAQ-SF | 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 |
| Epworth Sleepiness Scale (ESS) | 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 |
| Data Collection Form | 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. |
| Daily Total FODMAP Intake | 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. |
Countries
Turkey (Türkiye)
Contacts
STUDY_CHAIRSevde KAHRAMAN, Asst. Prof.
Biruni University
STUDY_DIRECTORZeynep Çavdar, Master's student and dietitan
Biruni University
PRINCIPAL_INVESTIGATORKoray Koçhan, Specialist of Gastroenterology
Department of Gastroenterology, Biruni University Faculty of Medicine Hospital
PRINCIPAL_INVESTIGATORHuri Demirci, PhD, Associate Professor
Biruni University
STUDY_CHAIRFatma Çelik, PhD, Professor
Biruni University
Outcome results
None listed