Frequency of Functional Gastrointestinal Disorders in Chi... | NCT04320550

Studies
Frequency of Functional Gastrointestinal Disorders in Children

NCT04320550

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Mar 26, 2020Actual

Enrollment

246Estimated

Phase

Not provided

Conditions

Functional Abdominal Pain Syndrome

Interventions

abdominal ultra sound

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 20, 2020Estimated

Primary Completion Date

Nov 30, 2021Estimated

Completion Date

Dec 30, 2021Estimated

First Submitted Date

Mar 23, 2020

First Submission Date that Met QC Criteria

Mar 23, 2020

First Posted Date

Mar 25, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2020

Last Update Posted Date

Mar 26, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

246Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
abdominal pain		one group of children complaining of recurrent abdominal pain	Diagnostic Test: abdominal ultra sound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
abdominal ultra sound	Diagnostic Test	non invasive tests to exclude pathological causes	abdominal pain

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
no structural or biochemical abnormality	percentage of functional gastrointestinal disorders	1 week

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
structural or biochemical abnormalities	percentage of causes of patholological recurrent abdominal pain	1 week

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

clinical diagnosis of recurrent abdominal pain
the child can express and locate site of the pain

Exclusion Criteria:

children less than 5 and adolescents more than 14
mentally retarded children

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

14 Years

Standard Ages

Child

Study Population

children with recurrent abdominal pain will be subjected to medical history , detailed examination and some investigations

Sampling Method

Non-Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30216016	Result	Reust CE, Williams A. Recurrent Abdominal Pain in Children. Am Fam Physician. 2018 Jun 15;97(12):785-793.
28594620	Result	Chopra 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.

ID	Term
D015746	Abdominal Pain
D012008	Recurrence

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D002452	Cell Count
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures