跳至主要内容
临床试验/NCT05738343
NCT05738343尚未招募不适用

Adesione Alla Dieta Mediterranea Dei Pazienti Pediatrici Affetti Dalla Sindrome Dell'Intestino Irritabile (IBS): Studio Pilota

University of Roma La Sapienza0 个研究点目标入组 50 人开始时间: 2023年2月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
主要终点
pediatric patients with IBS adherence to the Mediterranean diet

研究概览

简要总结

The goal of this observational study is to observe pediatric patients with IBS (irritable bowel syndrome). The main question it aims to answer are:

  • adherence to the Mediterranean diet of children with IBS
  • in patients not adhering to the Mediterranean diet, evaluate the efficacy of the nutritional intervention Participants will be visited, blood samples will be taken, abdomen ultrasound and they will answer questionnaires.

详细描述

The goal of this observational study is to observe pediatric patients with IBS (irritable bowel syndrome). the diagnosis of IBS will be placed in reference to the Rome IV criteria. To make a diagnosis, at least 2 of:

  • abdominal pain for at least 4 days per month associated with one or more of: pain associated with bowel movements, change in bowel frequency, change in stool consistency must be present.
  • In children with constipation, pain persists as the constipation resolves.
  • The symptoms are not explained by another medical condition. Participants will be visited, blood samples will be taken, abdomen ultrasound if necessary will be performed and they will answer questionnaires.

The main question it aims to answer are:

  • adherence to the Mediterranean diet of children with IBS
  • in patients not adhering to the Mediterranean diet, evaluate the efficacy of the nutritional intervention. if BMI between 5 and 85, nutritional education will be carried out for a healthy and correct diet. If BMI between 85 and 95 or greater than 95, personalized Mediterranean food scheme.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • diagnosis of IBS, based on Rome IV criteria.

排除标准

  • use of NSAIDs in the last 3 months;
  • allergies or intolerances;
  • recent diagnosis (last 3 months) of bacterial or parasitic infections of the gastrointestinal tract;
  • psychiatric diseases;
  • chronic inflammatory diseases of the gastrointestinal tract.

结局指标

主要结局

pediatric patients with IBS adherence to the Mediterranean diet

时间窗: Day 0

adherent patients on enrolled patients

次要结局

  • How many pediatric IBS patients who do not adhere to the Mediterranean diet, respond to nutritional intervention?(Day 7)

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Giovanni Di Nardo

Professor

University of Roma La Sapienza

相似试验