NCT05605405

Brief Summary

The definition of Functional Gastrointestinal Disorders (FGIDs) has changed over time from the absence of organic disease to a stress-related or psychiatric disorder to a motility disorder, and with Rome III, to a disorder of GI functioning, then Rome iv in 2016 defined FGIDs as : disorders of gut-brain interaction. It is a group of disorders classified by GI symptoms related to any combination of the following: motility disturbance, visceral hypersensitivity,altered mucosal and immune function, altered gut microbiota, and altered central nervous system (CNS) processing. FGIDs are observed in infants and young children worldwide with variable frequency related studies done in variable places around the worled show the following results : the prevalence of FGIDs in Chinese infants and young children is 27.3%.and 40 % in south american infants and 30 % of african infants and 35.1 % of infants presented to tertiary care hospital in Istunbul.Turkey.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
269

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2021

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

November 4, 2022

Completed
27 days until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

November 4, 2022

Status Verified

October 1, 2022

Enrollment Period

9 months

First QC Date

September 22, 2021

Last Update Submit

October 29, 2022

Conditions

Functional Gastrointestinal Disorders

Outcome Measures

Primary Outcomes (2)

  • Prevalence of functional gastrointestinal disorders among children attending gastrointerology clinic of Assuit University Children Hospital

    A number will calculated

    50 weeks

  • The associated factors

    Demographic and social

    50 weeks

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Children having functional GI symptoms according Rome IV criteria

You may qualify if:

  • Age group 1 to 18 years old

You may not qualify if:

  • Age group bwlow 1 year and above 18 years
  • Having other git problem as :
  • GIT bleeding
  • H pylori infection
  • Cow's milk protein allergy or IBD or any other symptoms suggestive to organic GI disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Central Study Contacts

Dalia Galal Mahran, MD

CONTACT

01007120821Daliaym2001@yahoo.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prevalence and associated factors of functional gastrointestinal disorders among children attending Assuit University Children Hospital

Study Record Dates

First Submitted

September 22, 2021

First Posted

November 4, 2022

Study Start

December 1, 2022

Primary Completion

September 1, 2023

Study Completion

December 1, 2023

Last Updated

November 4, 2022

Record last verified: 2022-10