Multi-center Study on Pediatric Functional Gastrointestinal Disorders in Mainland China

• Conditions: Functional Gastrointestinal Disorders

• Registration Number: NCT04388137
• Lead Sponsor: Zhejiang University

Brief Summary

This study plans to understand the prevalence and clinical characteristics of pediatric functional gastrointestinal disorders in mainland China through multi-center investigation and clinical epidemiological analysis, to reveal the prevalence characteristics and related factors of functional gastrointestinal disorders in children of all ages in mainland China, to establish a diagnostic standard system for pediatric functional gastrointestinal disorders in mainland China, to provide evidence-based basis for the formulation of new Roman standard for functional gastrointestinal disorders, and to provide new ideas and treatment basis for the diagnosis and treatment of functional gastrointestinal disorders in children.

Detailed Description

Functional gastrointestinal disorders (FGIDs), also known as brain-intestinal interaction abnormalities, are associated with dynamic disorders, high visceral sensitivity, changes in mucosal and immune functions, changes in intestinal flora, and abnormal central nervous system regulatory functions. FGIDs are the most common causes of diagnosis and treatment of gastrointestinal diseases in children. During the past 10 years, new progress has been made in the study of various FGIDs in children of different ages. FGIDs Rome Commission of Experts revised the relevant diagnostic criteria and officially published the Rome IV criteria for pediatric FGIDs in Gastroenterology in 2016. Due to many factors, the epidemiological survey data of pediatric FGID are still lacking in China. Whether Rome II, Rome III or Rome IV, their diagnostic criteria and epidemiological data were from other countries and regions, so their suitability for China's children remains to be verified. This study plans to understand the prevalence and clinical characteristics of pediatric functional gastrointestinal disorders in mainland China through multi-center investigation and clinical epidemiological analysis, to reveal the prevalence characteristics and related factors of functional gastrointestinal disorders in children of all ages in mainland China, to establish a diagnostic standard system for pediatric functional gastrointestinal disorders in mainland China, to provide evidence-based basis for the formulation of new Roman standard for functional gastrointestinal disorders, and to provide new ideas and treatment basis for the diagnosis and treatment of pediatric functional gastrointestinal disorders.

Study Timeline

• Study First Submitted: 2020-04-19
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-11
• Last Update Submitted: 2020-05-11
• Study First Posted: 2020-05-14
• Last Update Posted: 2020-05-14
• Study Start: 2020-06-01
• Primary Completion: 2022-01-01
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• Children diagnosed with functional gastrointestinal disorders

Exclusion Criteria

• Children not diagnosed with functional gastrointestinal disorders

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the prevalence rate	From date of finishing the disease diagnosis until the date of statistical analysis completed, assessed up to 6 months	the prevalence rate of pediatric functional gastrointestinal disorders in mainland China

Secondary Outcome Measures

Name	Time	Method
the Rome IV questionnaire	From date of finishing the questionnaire until the date of statistical information completed, assessed up to 3 months	to understand the clinical characteristics of pediatric functional gastrointestinal disorders in mainland China