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

NCT ID: NCT04388137

Last Updated: 2020-05-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2022-06-01

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.

Conditions

Functional Gastrointestinal Disorders

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

infants aged 0-3

No intervention.

No intervention.

Intervention Type: OTHER

No intervention.

children aged 4-18

No intervention.

No intervention.

Intervention Type: OTHER

No intervention.

Interventions

No intervention.

No intervention.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Children diagnosed with functional gastrointestinal disorders

Exclusion Criteria

• Children not diagnosed with functional gastrointestinal disorders

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Mizu Jiang

Director of National Clinical Research Center for Child Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mizu Mizu, Doctor

Role: PRINCIPAL_INVESTIGATOR

National Clinical Research Center for Child Health

Central Contacts

Mizu Mizu, Doctor

Role: CONTACT

mizu@zju.edu.cn

86-057187061007 ext. 86-05718706100

References

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.

Reference Type: BACKGROUND

PMID: 26513617 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 27144631 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29398057 (View on PubMed)

Saps M, Moreno-Gomez JE, Ramirez-Hernandez 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.

Reference Type: BACKGROUND

PMID: 29382524 (View on PubMed)

Other Identifiers

MZJiang

Identifier Type: -

Identifier Source: org_study_id