Functional Abdominal Pain SyndromeNCT04320550
Frequency of Functional Gastrointestinal Disorders in Children
An observational study of Functional Abdominal Pain Syndrome, run by Assiut University.
Trial summary
cross sectional study to detect frequency of functional gastrointestinal disorders among schhol aged children complaining of recurrent abdominal pain Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Functional Abdominal Pain Syndrome
- What is being tested?
- abdominal ultra sound
- How many people
- 246 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2020to 30 Dec 2021
- 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 5 to 14 years
- All sexes
- Child
Study population: children with recurrent abdominal pain will be subjected to medical history , detailed examination and some investigations
Who may be able to join
- clinical diagnosis of recurrent abdominal pain
- the child can express and locate site of the pain
Who cannot join
- children less than 5 and adolescents more than 14
- mentally retarded children
About this study
Official title: Frequency of Functional Gastrointestinal Disorders Among School Aged Children
cross sectional study to detect frequency of functional gastrointestinal disorders among schhol aged children complaining of recurrent abdominal pain
Read the detailed description
school aged children from age of 5 to age of 15 who are complaining of recurrent abdominal pain will be included in the study , detailed history , examination and investigations will be done
- Conditions
- Functional Abdominal Pain Syndrome
- Being tested
- abdominal ultra sound
- Keywords
- abdominal pain, recurrent
- Medical subject headings
- Abdominal Pain, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abdominal ultra soundDiagnostic test
Also called complete blood count, Erythrocyte sidementation rate, C reactive protein
non invasive tests to exclude pathological causes
| Study group | Role | What they receive |
|---|---|---|
| abdominal pain | one group of children complaining of recurrent abdominal pain Receives: Diagnostic Test: abdominal ultra sound |
What is being measured
The primary outcome is the main question the study is designed to answer.
no structural or biochemical abnormality
percentage of functional gastrointestinal disorders
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start20 Dec 2020 (estimated)
- Primary completion30 Nov 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Functional Abdominal Pain SyndromeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hend Ali Zohrey, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04320550
- Sponsor's protocol ID
- FGIDs
- Status last verified
- Mar 2020
- First submitted
- 23 Mar 2020
- Last updated
- 26 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Reust CE, Williams A. Recurrent Abdominal Pain in Children. Am Fam Physician. 2018 Jun 15;97(12):785-793.
PubMed 30216016Chopra J, Patel N, Basude D, Gil-Zaragozano E, Paul SP. Abdominal pain-related functional gastrointestinal disorders in children. Br J Nurs. 2017 Jun 8;26(11):624-631. doi: 10.12968/bjon.2017.26.11.624.
PubMed 28594620
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Functional Gastrointestinal Disorders Among School Aged Children
- ClinicalTrials.gov ID
- NCT04320550
- Acronym / sponsor ID
- FGIDs
- Conditions
- Functional Abdominal Pain Syndrome
- Keywords
- abdominal pain, recurrent
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Dec 2020 (estimated)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 25 Mar 2020 (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.
cross sectional study to detect frequency of functional gastrointestinal disorders among schhol aged children complaining of recurrent abdominal pain
Detailed description
school aged children from age of 5 to age of 15 who are complaining of recurrent abdominal pain will be included in the study , detailed history , examination and investigations will be done
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| abdominal pain | – | Diagnostic Test: abdominal ultra soundone group of children complaining of recurrent abdominal pain |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Age groups
- Child
- Study population
- children with recurrent abdominal pain will be subjected to medical history , detailed examination and some investigations
Key inclusion criteria (2 listed)
- clinical diagnosis of recurrent abdominal pain
- the child can express and locate site of the pain
Key exclusion criteria (2 listed)
- children less than 5 and adolescents more than 14
- mentally retarded children
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| abdominal ultra soundAlso: complete blood count, Erythrocyte sidementation rate, C reactive proteinnon invasive tests to exclude pathological causes | Diagnostic test | abdominal pain |
Primary outcome
no structural or biochemical abnormality
Time frame: 1 week
percentage of functional gastrointestinal disorders
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Results publication: PubMed 30216016Reust CE, Williams A. Recurrent Abdominal Pain in Children. Am Fam Physician. 2018 Jun 15;97(12):785-793.
- Results publication: PubMed 28594620Chopra J, Patel N, Basude D, Gil-Zaragozano E, Paul SP. Abdominal pain-related functional gastrointestinal disorders in children. Br J Nurs. 2017 Jun 8;26(11):624-631. doi: 10.12968/bjon.2017.26.11.624.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Abdominal Pain Syndrome, 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 2 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 26 Mar 2020. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
no structural or biochemical abnormality (time frame: 1 week). 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 NCT04320550, which also lists 2 linked publications.
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 26 Mar 2020.