- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05605405
Prevalence and Associated Factors of Functional Gastrointestinal Disorders Among Children
October 29, 2022 updated by: Ahlam Osama, Assiut University
Prevalence and Associated Factors of Functional Gastrointestinal Disorders Among Children Attending Assuit University Children Hospital
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.
Study Overview
Status
Not yet recruiting
Conditions
Detailed 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 .
Study Type
Observational
Enrollment (Anticipated)
269
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dalia Galal Mahran, MD
- Phone Number: 01007120821
- Email: Daliaym2001@yahoo.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Children having functional GI symptoms according Rome IV criteria
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of functional gastrointestinal disorders among children attending gastrointerology clinic of Assuit University Children Hospital
Time Frame: 50 weeks
|
A number will calculated
|
50 weeks
|
|
The associated factors
Time Frame: 50 weeks
|
Demographic and social
|
50 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 1, 2022
Primary Completion (Anticipated)
September 1, 2023
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
September 22, 2021
First Submitted That Met QC Criteria
October 29, 2022
First Posted (Actual)
November 4, 2022
Study Record Updates
Last Update Posted (Actual)
November 4, 2022
Last Update Submitted That Met QC Criteria
October 29, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PAAFOFGDACAAUCH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Functional Gastrointestinal Disorders
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-
Umeå UniversityCompletedFunctional Gastrointestinal DisorderSweden
-
The University of Texas Medical Branch, GalvestonCompletedGastrointestinal Disorders, Functional
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Dr Anne PayneUniversity of LondonUnknownFunctional Gastrointestinal Disorders in ChildrenUnited Kingdom
-
Chang Gung Memorial HospitalNew Bellus EnterprisesUnknownNeoplasm | Functional Gastrointestinal DisorderTaiwan
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BayerCompletedA Pharmacy-based Observational Study to Learn More About Iberogast Advance in the Real-world SettingFunctional Dyspepsia | Irritable Bowel Syndrome | Functional Gastrointestinal Disorders Such as Irritable Bowel Syndrome and Functional DyspepsiaGermany
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Maanshan Shiqiye HospitalInstitute of Process Engineering, Chinese Academy of SciencesNot yet recruitingFunctional Gastrointestinal Disorders
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Biao ZouRecruitingFunctional Gastrointestinal DisordersChina