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

Functional Gastrointestinal Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04388137
• Other study ID #: MZJiang
• Status: Not yet recruiting
• Start date: June 1, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: May 2020
• Source: Zhejiang University
• Contact: Mizu Mizu, Doctor
• Phone: 86-057187061007
• Email: mizu[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: June 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Children diagnosed with functional gastrointestinal disorders

Exclusion Criteria:

• Children not diagnosed with functional gastrointestinal disorders

Related Conditions & MeSH terms

• Digestive System Diseases
• Disease
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases

Intervention

Other:
• No intervention.
No intervention.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

References & Publications (4)

Benninga MA, Faure C, Hyman PE, St James Roberts I, Schechter NL, Nurko S. Childhood Functional Gastrointestinal Disorders: Neonate/Toddler. Gastroenterology. 2016 Feb 15. pii: S0016-5085(16)00182-7. doi: 10.1053/j.gastro.2016.02.016. [Epub ahead of print] — View Citation

Robin SG, Keller C, Zwiener R, Hyman PE, Nurko S, Saps M, Di Lorenzo C, Shulman RJ, Hyams JS, Palsson O, van Tilburg MAL. Prevalence of Pediatric Functional Gastrointestinal Disorders Utilizing the Rome IV Criteria. J Pediatr. 2018 Apr;195:134-139. doi: 10.1016/j.jpeds.2017.12.012. Epub 2018 Feb 3. — View Citation

Rouster AS, Karpinski AC, Silver D, Monagas J, Hyman PE. Functional Gastrointestinal Disorders Dominate Pediatric Gastroenterology Outpatient Practice. J Pediatr Gastroenterol Nutr. 2016 Jun;62(6):847-51. doi: 10.1097/MPG.0000000000001023. — View Citation

Saps M, Moreno-Gomez JE, Ramírez-Hernández CR, Rosen JM, Velasco-Benitez CA. A nationwide study on the prevalence of functional gastrointestinal disorders in school-children. Bol Med Hosp Infant Mex. 2017 Nov - Dec;74(6):407-412. doi: 10.1016/j.bmhimx.2017.05.005. Epub 2017 Sep 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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