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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05605405
Other study ID # PAAFOFGDACAAUCH
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 2022
Est. completion date December 2023

Study information

Verified date October 2022
Source Assiut University
Contact Dalia Galal Mahran, MD
Phone 01007120821
Email Daliaym2001@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

The etiology of these disorders remains uncertain and thought to be due to subtle alteration of the normal development or maladaptive behavioral response to a variety of internal or external stimuli .As a group of disorders; FGIDs in young children are a major challenge to the already overstretched pediatric gastroenterology services across the world .Infants and young children with FGIDs visit medical professionals more frequently and experience poor quality of life . In addition, FGIDs in infancy are linked with detrimental repercussions such as maternal depression, poor infant and mother bonding,and poor physical growth .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 269
Est. completion date December 2023
Est. primary completion date September 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Year to 18 Years
Eligibility Inclusion Criteria: - Age group 1 to 18 years old Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of functional gastrointestinal disorders among children attending gastrointerology clinic of Assuit University Children Hospital A number will calculated 50 weeks
Primary The associated factors Demographic and social 50 weeks
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