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

NCT04388137 | Unknown DMC

• 1 other identifier: MZJiang
• Study Type: observational
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Functional Gastrointestinal Disorders

Keywords

functional gastrointestinal disorders; children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• the Rome IV questionnaire

  From date of finishing the questionnaire until the date of statistical information completed, assessed up to 3 months

Study Arms (2)

infants aged 0-3

No intervention.

Other: No intervention.

children aged 4-18

No intervention.

Other: No intervention.

Interventions

No intervention. OTHER

No intervention.

children aged 4-18; infants aged 0-3

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children who visit the gastroenterology department due to gastrointestinal symptoms

You may qualify if:

• Children diagnosed with functional gastrointestinal disorders

You may not qualify if:

• Children not diagnosed with functional gastrointestinal disorders

Sponsors & Collaborators

• Zhejiang University: lead

Related Publications (4)

• 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.

  PMID: 26513617 BACKGROUND

• 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.

  PMID: 27144631 BACKGROUND

• 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.

  PMID: 29398057 BACKGROUND

• 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.

  PMID: 29382524 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Mizu Mizu, Doctor

  National Clinical Research Center for Child Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mizu Mizu, Doctor

CONTACT

86-057187061007; mizu@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of National Clinical Research Center for Child Health

Study Record Dates

• First Submitted: April 19, 2020
• First Posted: May 14, 2020
• Study Start: June 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: June 1, 2022
• Last Updated: May 14, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share