CClinicalTrials.gg
Status unknownNCT04388137Updated May 14, 2020

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

An observational study in Functional Gastrointestinal Disorders, sponsored by Zhejiang University. Status unknown. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2020-05-14.

Sponsored by Zhejiang University · Observational

The sponsor has not verified this record recently (last verified May 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,500
Ages
Up to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Functional Gastrointestinal Disorders

Keywords

  • functional gastrointestinal disorders
  • children
03

In context

Gastrointestinal Diseases

628 studies on the registry are indexed under Gastrointestinal Diseases; 128 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 325 across 190 observational studies indexed under Gastrointestinal Diseases.

Browse Gastrointestinal Diseases studies →

Lead sponsor

Zhejiang University is the lead sponsor of 351 studies on the registry; 165 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children who visit the gastroenterology department due to gastrointestinal symptoms

Inclusion criteria

  • Children diagnosed with functional gastrointestinal disorders

Exclusion criteria

Exclusion Criteria:

  • Children not diagnosed with functional gastrointestinal disorders
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,500 participants (estimated)
Patient registry
No

Groups and cohorts

  • infants aged 0-3

    No intervention.

    Other: No intervention.

  • children aged 4-18

    No intervention.

    Other: No intervention.

Interventions

  • OtherNo intervention.

    No intervention.

06

What researchers measure

Primary outcomes

  1. the prevalence rate

    the prevalence rate of pediatric functional gastrointestinal disorders in mainland China

    Time frame: 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

    to understand the clinical characteristics of pediatric functional gastrointestinal disorders in mainland China

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 26513617 ↗
  • 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. PubMed 27144631 ↗
  • 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. PubMed 29398057 ↗
  • 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. PubMed 29382524 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04388137
Lead sponsor
Zhejiang University
Responsible party
Mizu Jiang (Director of National Clinical Research Center for Child Health, Zhejiang University) — Principal investigator
First posted
May 14, 2020
Start date
Jun 1, 2020 (estimated)
Primary completion
Jan 1, 2022 (estimated)
Completion
Jun 1, 2022 (estimated)
Last update
May 14, 2020

Study contacts

Mizu Mizu, Doctor
Contact
mizu@zju.edu.cn
86-057187061007 ext. 86-05718706100
Mizu Mizu, Doctor
principal investigator · National Clinical Research Center for Child Health

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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