Chronic Constipation in ChildrenNCT04110158
Chronic Constipation in Children Among School Children is Assuit University Children Hospital
An observational study of Chronic Constipation in Children, run by Assiut University.
Trial summary
Aim of the work to show rate of constipation among school age children in Assuit University Children Hospital Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Chronic Constipation in Children
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2019to Nov 2020
- 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 4 to 18 years
- All sexes
- Child, Adult
Study population: Children between 4:18 years old complain of constipation for a period long than 2 months
Who may be able to join
- Exclusion Criteria: neonates and younger than 4years children
- -
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Study on Chronic Constipation Etiology and Risk Factors Among School Age Children in Assuit University Children Hospital
Aim of the work to show rate of constipation among school age children in Assuit University Children Hospital
Read the detailed description
Childhood constipation is a frequently overlooked global health problem, which is developing in a public health issue in many parts of the world.(1) Constipation is one of the commonest digestive complaints in children(2) Constipation has long been considered a symptom, rather than a disease(3)
It is often perceived as infrequent motions or passage of hard stools. Some defined constipation as less than 3 bowel motions per week)4(
or as difficulty in passing stools (5) Approximately 0.5% of school children have defecation frequency less than 3 per week and 0.3% have fecal incontinence(6) Furthermore, 20% of children also have at least 1 clinical feature of constipation.7 Therefore, it is important to use diagnostic criteria based on multiple symptoms to define constipation
- Conditions
- Chronic Constipation in Children
What is being measured
The primary outcome is the main question the study is designed to answer.
A.study on chronic Constipation Etiology and risk factors among school age children in Assuit University Children Hospital
Constipation, risk factors ,management and outcomes
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start15 Oct 2019 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Constipation in ChildrenStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Ahmed Mohamed Hussien, Assiut University
- Investigators
- Mostafa Tawfeek, Study director, Mustafa.tawfeek1@med.au.edu.eg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04110158
- Sponsor's protocol ID
- Chronic constipation
- Status last verified
- Sep 2019
- First submitted
- 27 Sep 2019
- Last updated
- 1 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rajindrajith S, Devanarayana NM. Constipation in children: novel insight into epidemiology, pathophysiology and management. J Neurogastroenterol Motil. 2011 Jan;17(1):35-47. doi: 10.5056/jnm.2011.17.1.35. Epub 2011 Jan 26.
PubMed 21369490
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Chronic Constipation Etiology and Risk Factors Among School Age Children in Assuit University Children Hospital
- ClinicalTrials.gov ID
- NCT04110158
- Acronym / sponsor ID
- Chronic constipation
- Conditions
- Chronic Constipation in Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Oct 2019 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 1 Oct 2019 (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.
Aim of the work to show rate of constipation among school age children in Assuit University Children Hospital
Detailed description
Childhood constipation is a frequently overlooked global health problem, which is developing in a public health issue in many parts of the world.(1) Constipation is one of the commonest digestive complaints in children(2) Constipation has long been considered a symptom, rather than a disease(3)
It is often perceived as infrequent motions or passage of hard stools. Some defined constipation as less than 3 bowel motions per week)4(
or as difficulty in passing stools (5) Approximately 0.5% of school children have defecation frequency less than 3 per week and 0.3% have fecal incontinence(6) Furthermore, 20% of children also have at least 1 clinical feature of constipation.7 Therefore, it is important to use diagnostic criteria based on multiple symptoms to define constipation
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children between 4:18 years old complain of constipation for a period long than 2 months
Key inclusion criteria (2 listed)
- Exclusion Criteria: neonates and younger than 4years children
- -
Key exclusion criteria (0 listed)
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
A.study on chronic Constipation Etiology and risk factors among school age children in Assuit University Children Hospital
Time frame: Baseline
Constipation, risk factors ,management and outcomes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Background: PubMed 21369490Rajindrajith S, Devanarayana NM. Constipation in children: novel insight into epidemiology, pathophysiology and management. J Neurogastroenterol Motil. 2011 Jan;17(1):35-47. doi: 10.5056/jnm.2011.17.1.35. Epub 2011 Jan 26.
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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.
Mostafa Tawfeek study director
Mustafa.tawfeek1@med.au.edu.eg
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Constipation in Children, 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 2 inclusion and 0 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 1 Oct 2019. 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 Fatma Hussein (+01069677753, Fatma.lafy10@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A.study on chronic Constipation Etiology and risk factors among school age children in Assuit University Children Hospital (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04110158, which also lists 1 linked publication.
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 1 Oct 2019.