- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07154940
- Original Trial
Diagnostic Yeild of Esophagogastrodudenoscopy in Pediatric Chronic Abdominal Pain
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Children aged 6 to 18 years presenting with chronic abdominal pain which defined according to the Rome IV criteria as persistent or recurring abdominal pain that has been present for at least 3 months, with symptom onset at least 6 months prior to diagnosis. This pain must be continuous or nearly continuous, and only occasionally related to physiological events like eating or defecation. Furthermore, the pain must limit some aspect of daily functioning, and it is not feigned or explained by another medical condition and referred to GIT unit for Esophagogastroduodenoscopy and not undertreatment based on clinical judgment due to the presence of one or more of the following:
- Alarm symptoms (e.g., weight loss, anemia, Hematemesis, Dysphagia, persistent vomiting, nocturnal pain)
- Failure of empiric therapy (e.g., proton pump inhibitors or dietary modifications)
- Suspicion of an underlying organic disease (e.g., celiac disease or Helicobacter pylori infection)
Exclusion criteria:
- Acute abdominal pain
- Children aged less than 6 years and more than 18 years
- Recent use of proton pump inhibitors (within 2 weeks) or antibiotics (within 4 weeks) before endoscopy.
- Children meeting the criteria of functional abdominal pain according to Rome IV criteria in which was defined as as recurrent or chronic abdominal pain that is not explained by another medical condition and is not solely associated with physiological events like eating or menstruation. It must occur at least 4 times per month for at least 2 months, and diagnostic evaluation should rule out other conditions .
- Children with contraindications to undergoing EGD (e.g., severe respiratory or cardiac conditions).
- Children who refuse to participate or whose parents do not provide consent.
- Children previously diagnosed with recurrent abdominal pain -
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Determine the prevalence of endoscopic and histopathological abnormalities in symptomatic children undergoing esophagogastrodudenoscopy for chronic abdominal pain
Time Frame: Oct 2025 to april 2027
|
Oct 2025 to april 2027
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AUCH AssiutU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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