Functional Gastrointestinal DisordersNCT05605405
Prevalence and Associated Factors of Functional Gastrointestinal Disorders Among Children
An observational study of Functional Gastrointestinal Disorders, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 1 year to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Gastrointestinal Disorders
- How many people
- 269 participants
- Where
- No sites listed yet
- Study dates
- Dec 2022to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children having functional GI symptoms according Rome IV criteria
Who may be able to join
- Age group 1 to 18 years old
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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 .
- Conditions
- Functional Gastrointestinal Disorders
- Medical subject headings
- Gastrointestinal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of functional gastrointestinal disorders among children attending gastrointerology clinic of Assuit University Children Hospital
A number will calculated
Measured: 50 weeks
The associated factors
Demographic and social
Measured: 50 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study startDec 2022 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Gastrointestinal DisordersStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 269 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahlam Osama, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05605405
- Sponsor's protocol ID
- PAAFOFGDACAAUCH
- Status last verified
- Oct 2022
- First submitted
- 22 Sep 2021
- Last updated
- 4 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Associated Factors of Functional Gastrointestinal Disorders Among Children Attending Assuit University Children Hospital
- ClinicalTrials.gov ID
- NCT05605405
- Acronym / sponsor ID
- PAAFOFGDACAAUCH
- Conditions
- Functional Gastrointestinal Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 269 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 4 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children having functional GI symptoms according Rome IV criteria
Key inclusion criteria (1 listed)
- Age group 1 to 18 years old
Key exclusion criteria (5 listed)
- Age group bwlow 1 year and above 18 years
- GIT bleeding
- H pylori infection
- Cow's milk protein allergy or IBD or any other symptoms suggestive to organic GI disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of functional gastrointestinal disorders among children attending gastrointerology clinic of Assuit University Children Hospital
Time frame: 50 weeks
A number will calculated
The associated factors
Time frame: 50 weeks
Demographic and social
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Gastrointestinal Disorders, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dalia Galal Mahran, MD (01007120821, Daliaym2001@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of functional gastrointestinal disorders among children attending gastrointerology clinic of Assuit University Children Hospital (time frame: 50 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.