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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Istanbul
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Istanbul, Istanbul, 터키 (Türkiye)
- Biruni University Faculty of Medicine Hospital
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Istanbul, Istanbul, 터키 (Türkiye)
- Biruni University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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활성 비교기: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
IBS-SSS
기간: 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
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GSRS
기간: From enrollment to the end of treatment at 8 weeks
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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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Anthropometric measurement data
기간: From enrollment to the end of treatment at 8 weeks
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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
기간: From enrollment to the end of treatment at 8 weeks
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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)
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 연구 의자: Sevde KAHRAMAN, Asst. Prof., Biruni University
- 연구 책임자: Zeynep Çavdar, Master's student and dietitan, Biruni University
- 수석 연구원: Koray Koçhan, Specialist of Gastroenterology, Department of Gastroenterology, Biruni University Faculty of Medicine Hospital
- 수석 연구원: Huri Demirci, PhD, Associate Professor, Biruni University
- 연구 의자: Fatma Çelik, PhD, Professor, Biruni University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2015-KAEK-80-23-49/SKLOWFODMAP
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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