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临床试验/NCT07619573
NCT07619573已完成不适用

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

Biruni University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
2

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18-65 years.
  • Diagnosed with IBS according to the Rome IV criteria.

排除标准

  • Use of antibiotics, NSAIDs, oral contraceptives, or hormone therapy during the study.
  • Pregnancy or breastfeeding.
  • Diagnosis of celiac disease

研究者

发起方
Biruni University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sevde Kahraman

Asst. Prof.

Biruni University

研究点 (2)

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