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临床试验/NCT07539077
NCT07539077已完成不适用

Prevalence of Disorders of Gut-Brain-Interaction in Pediatric Patients With In-remission Inflammatory Bowel Disease: an Italian Multicenter Study

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2025年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
220
试验地点
1
主要终点
Prevalence of commonly reported DGBIs in pediatric patients with quiescent IBD, compared to a control group of healthy children.

研究概览

简要总结

The medical management of inflammatory bowel disease (IBD) has evolved over the years thanks to the newly available therapies and the biochemical and endoscopic monitoring of the disease. Several in-remission IBD patients still complain of gastrointestinal symptoms, suggesting a possible overlap between IBD and Disorders of Gut-Brain-Interaction (DGBIs), classified and diagnosed according to the Rome IV criteria, with a worldwide prevalence of about 40% in the general population. In adult patients with in-remission IBD, the prevalence of any DGBI has been reported to reach up to 41%, resulting in significantly higher rates in Crohn's disease (CD) than in ulcerative colitis (UC). Regarding the pediatric population, according to a meta-analysis conducted in 2015, the worldwide prevalence of functional abdominal pain disorders (FAPDs), a subtype of DGBIs including functional dyspepsia, irritable bowel syndrome (IBS), abdominal migraine, and functional abdominal pain not otherwise specified (FAP-NOS), in children is about 13.5%, with IBS reported as the most frequent disorder (8.8%). Only a few studies were conducted on pediatric patients to investigate the association between IBD and DGBIs. A meta-analysis conducted in 2022 reported an overall prevalence of FAPDs ranging between 9.6% and 29.5% in children with in-remission IBD, with the overall prevalence of IBS in these patients ranging between 3.9% and 16.1%. Therefore, despite the differences in criteria used to define quiescent IBD in the included studies, an increased overall prevalence of IBS and FAPDs in children with IBD was described. Nevertheless, none used the current Rome IV criteria to diagnose DGBIs, and only the prevalence of IBS and FAPDs was analyzed. The primary aim of our study was to assess the prevalence of commonly reported DGBIs (Functional nausea and vomiting disorders, Functional abdominal pain disorders, Functional defecation disorders) in pediatric patients with quiescent IBD, compared to a control group of healthy children. Secondly, we aimed to investigate the presence of any other factors associated with the presence of DGBIs in our population, regardless of the IBD status.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • In-remission IBD patients:
  • Clinical remission was defined as PUCAI/aPCDAI < 10
  • biochemical remission was defined as CRP < 0.5 mg/ml and faecal calprotectin < 100 microg/g
  • Endoscopic remission defined as CDEIS < 6 for CD and Mayo score ≤ 1 for UC.

排除标准

  • diabetes (type I and II)
  • thyroid disease
  • major abdominal surgery in the previous two years
  • connective tissue disease
  • ongoing corticosteroid or antibiotic therapy.

研究组 & 干预措施

Control group

healthy subjects were followed for periodic health and auxologic assessment

干预措施: DGBI prevalence (Other)

IBD group

in remission IBD pediatric patients

干预措施: DGBI prevalence (Other)

结局指标

主要结局

Prevalence of commonly reported DGBIs in pediatric patients with quiescent IBD, compared to a control group of healthy children.

时间窗: Baseline

Commonly reported DGBIs in pediatric patients

时间窗: Baseline

Prevalence of commonly reported DGBIs in pediatric patients with quiescent IBD, compared to a control group of healthy children.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor
主要研究者

Giorgio Valentina

MD, PhD

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

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