NCT04320550

Brief Summary

cross sectional study to detect frequency of functional gastrointestinal disorders among schhol aged children complaining of recurrent abdominal pain

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
246

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

December 20, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

12 months

First QC Date

March 23, 2020

Last Update Submit

March 24, 2020

Conditions

Functional Abdominal Pain Syndrome

Keywords

abdominal painrecurrent

Outcome Measures

Primary Outcomes (1)

  • no structural or biochemical abnormality

    percentage of functional gastrointestinal disorders

    1 week

Other Outcomes (1)

  • structural or biochemical abnormalities

    1 week

Study Arms (1)

abdominal pain

one group of children complaining of recurrent abdominal pain

Diagnostic Test: abdominal ultra sound

Interventions

abdominal ultra soundDIAGNOSTIC_TEST

non invasive tests to exclude pathological causes

Also known as: complete blood count, Erythrocyte sidementation rate, C reactive protein
abdominal pain

Eligibility Criteria

Age5 Years - 14 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Reust CE, Williams A. Recurrent Abdominal Pain in Children. Am Fam Physician. 2018 Jun 15;97(12):785-793.

    PMID: 30216016RESULT

  • 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.

    PMID: 28594620RESULT

MeSH Terms

Conditions

Abdominal PainRecurrence

Interventions

Blood Cell Count

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

Cell CountCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHematologic TestsInvestigative TechniquesCell Physiological PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

March 23, 2020

First Posted

March 25, 2020

Study Start

December 20, 2020

Primary Completion

November 30, 2021

Study Completion

December 30, 2021

Last Updated

March 26, 2020

Record last verified: 2020-03