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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04388137
Enrollment
1500
Registered
2020-05-14
Start date
2020-06-01
Completion date
2022-06-01
Last updated
2020-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Gastrointestinal Disorders

Keywords

functional gastrointestinal disorders, children

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.

Interventions

OTHERNo intervention.

No intervention.

Sponsors

Zhejiang University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

Inclusion criteria

* Children diagnosed with functional gastrointestinal disorders

Exclusion criteria

* Children not diagnosed with functional gastrointestinal disorders

Design outcomes

Primary

MeasureTime frameDescription
the prevalence rateFrom date of finishing the disease diagnosis until the date of statistical analysis completed, assessed up to 6 monthsthe prevalence rate of pediatric functional gastrointestinal disorders in mainland China

Secondary

MeasureTime frameDescription
the Rome IV questionnaireFrom date of finishing the questionnaire until the date of statistical information completed, assessed up to 3 monthsto understand the clinical characteristics of pediatric functional gastrointestinal disorders in mainland China

Contacts

Primary ContactMizu Mizu, Doctor
mizu@zju.edu.cn86-057187061007

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026