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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multi-center Study on the Establishment of Diagnostic Criteria System for Pediatric Functional Gastrointestinal Disorders in Mainland China

Conditions
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Functional Gastrointestinal Disorders

Intervention / Treatment
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* Other: No intervention.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children diagnosed with functional gastrointestinal disorders Exclusion Criteria: Children not diagnosed with functional gastrointestinal disorders

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| infants aged 0-3<br>No intervention. | Other: No intervention.<br>* No intervention.<br>|
| children aged 4-18<br>No intervention. | Other: No intervention.<br>* No intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the prevalence rate | the prevalence rate of pediatric functional gastrointestinal disorders in mainland China | From date of finishing the disease diagnosis until the date of statistical analysis completed, assessed up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Rome IV questionnaire | to understand the clinical characteristics of pediatric functional gastrointestinal disorders in mainland China | From date of finishing the questionnaire until the date of statistical information completed, assessed up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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functional gastrointestinal disorders, children