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Functional Gastrointestinal Disorders in Pediatric IBD (TFI-MICI)

2020年11月16日更新者：University Hospital, Caen

Functional Gastrointestinal Disorders in Children and Adolescents With Inflammatory Bowel Disease in Remission: Prevalence and Identification of Clinical and Psychosocial Risk Factors

Background: Persistent gastrointestinal symptoms have been described in patients who are considered in remission of their inflammatory bowel disease (IBD). These symptoms, attributed to Functional gastrointestinal disorders (FGID) in IBD, may have a significant impact of quality of life, and may be associated with fatigue, anxiety and depression. There is very little data regarding pediatric specificities of these FGID.

Aims: The aim of the study is to evaluate the prevalence of FGID in pediatric patients with IBD in remission. Secondary aims are to investigate a possible association of FGID with fatigue, anxiety, depression and impacted quality of life in the patients, as well as anxiety and depression in the parents.

Methods: This will be an observational, case-control study. All patients between 9 and 18 years old , with IBD in remission will be invited to participate. Questionnaires will be web-based and will evaluate: presence of FGID (Fr-qPGS), fatigue (FACIT-F), anxiety (SCARED-R), depression (CDI), quality of life (IMPACT-III). Parents will be invited to fill in web-based questionnaires on their symptoms of anxiety (STAI/Y-A and STAI/Y-B) and depression (BDI). Clinical parameters will be retrieved retrospectively from the chart. Level of remission will be confirmed by most recent blood tests and fecal calprotectin. Patients with FGID will be compared to patients without FGID in terms of clinical characteristics, disease phenotype and associated psychological comorbidities.

研究概览

地位

完全的

条件

研究类型

观察性的

注册 (实际的)

350

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

法国
- - Caen、法国
    - Caen University hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

9年至 18年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

In the aim of recruiting a sample that will be the most representative possible of the population of pediatric IBD patients in remission in France, patients will be recruited for the study through different procedures:

either during a routine visit to the pediatric gastroenterology clinic (all French pediatric gastroenterology clinics will be study centers)
or during a routine visit to the adult gastroenterology clinic (the French adult gastroenterologists will be informed of the study and will be able to apply to be a study center)
finally, the patient will be able to find information on the study through the French IBD patient Foundation (association Francois Aupetit) and contact the investigators in order to participate.

描述

Inclusion Criteria:

IBD (Crohns disease, Ulcerative colitis or IBD-U)
in remission (defined as: Physician's global assessment = remission, no nocturnal stools, no blood in stools, < or = 3 stools/day, C reactive protein < 10 mg/L, erythrocyte sedimentation rate < 20 mm, no flare of disease or change of treatment in the last 3 months, no ongoing corticosteroid therapy
followed for IBD for at least 1 year

Exclusion Criteria:

presence of an ileostomy or colostomy
past history of total colectomy
unable to understand written French or to answer the questionnaires

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

观测模型：病例对照
时间观点：横截面

团体/队列数

队列和干预

团体/队列
FGID-IBD Patients aged 9-18 years with inflammatory bowel disease (Crohns, ulcerative colitis or indeterminate colitis) in remission (defined as: Physician's global assessment = remission, no nocturnal stools, no blood in stools, < or = 3 stools/day, C-reactive-protein < 10 mg/L, Erythrocyte sedimentation rate < 20 mm, no flare of disease or change of treatment in the last 3 months, no ongoing corticosteroid therapy followed for IBD for at least 1 year with at least one Functional Gastrointestinal disorder according to the Fr-qPGS questionnaire (Rome III criteria)
No FGID-IBD Patients aged 9-18 years with inflammatory bowel disease (Crohns, ulcerative colitis or indeterminate colitis) in remission (defined as: Physician's global assessment = remission, no nocturnal stools, no blood in stools, < or = 3 stools/day, C-reactive-protein < 10 mg/L, Erythrocyte sedimentation rate < 20 mm, no flare of disease or change of treatment in the last 3 months, no ongoing corticosteroid therapy followed for IBD for at least 1 year not a single Functional Gastrointestinal disorder according to the Fr-qPGS questionnaire (Rome III criteria)

团体/队列

FGID-IBD

Patients aged 9-18 years
with inflammatory bowel disease (Crohns, ulcerative colitis or indeterminate colitis)
in remission (defined as: Physician's global assessment = remission, no nocturnal stools, no blood in stools, < or = 3 stools/day, C-reactive-protein < 10 mg/L, Erythrocyte sedimentation rate < 20 mm, no flare of disease or change of treatment in the last 3 months, no ongoing corticosteroid therapy
followed for IBD for at least 1 year
with at least one Functional Gastrointestinal disorder according to the Fr-qPGS questionnaire (Rome III criteria)

No FGID-IBD

Patients aged 9-18 years
with inflammatory bowel disease (Crohns, ulcerative colitis or indeterminate colitis)
in remission (defined as: Physician's global assessment = remission, no nocturnal stools, no blood in stools, < or = 3 stools/day, C-reactive-protein < 10 mg/L, Erythrocyte sedimentation rate < 20 mm, no flare of disease or change of treatment in the last 3 months, no ongoing corticosteroid therapy
followed for IBD for at least 1 year
not a single Functional Gastrointestinal disorder according to the Fr-qPGS questionnaire (Rome III criteria)

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Presence of Functional Gastrointestinal Disorder 大体时间：baseline	Rome III criteria for FGID (Fr-qPGS questionnaire)	baseline

次要结果测量

结果测量	措施说明	大体时间
Anxiety 大体时间：baseline	SCARED-R questionnaire	baseline
Depression 大体时间：baseline	CDI questionnaire	baseline
Quality of life - disease related 大体时间：baseline	IMPACT-III questionnaire	baseline
Fatigue 大体时间：baseline	peds FACIT-F questionnaire	baseline
Anxiety (parents) 大体时间：baseline	STAI/Y-A and STAI/Y-B questionnaires	baseline
Depression (parents) 大体时间：baseline	BDI questionnaire	baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University Hospital, Caen

调查人员

首席研究员：Claire Dupont-Lucas、Groupe d'Etudes Therapeutiques des Affections Inflammatoires Digestives pediatriques

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年4月3日

初级完成 (实际的)

2019年2月8日

研究完成 (实际的)

2020年11月8日

研究注册日期

首次提交

2018年2月9日

首先提交符合 QC 标准的

2018年6月19日

首次发布 (实际的)

2018年6月21日

研究记录更新

最后更新发布 (实际的)

2020年11月17日

上次提交的符合 QC 标准的更新

2020年11月16日

最后验证

2020年11月1日