NCT06783673

Brief Summary

The aim is to study the clinical, serological, endoscopic and histopathological characteristics and treatment outcome of children diagnosed with celiac disease in Sohag University Hospital

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 25, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 30, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 20, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2025

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

December 30, 2024

Last Update Submit

April 6, 2025

Conditions

Keywords

clinicopathological, endoscopic and serological patterns of celiac disease in children

Outcome Measures

Primary Outcomes (1)

  • Number of participants with Clinicopathological, endoscopic and serological patterns of Celiac disease

    clinical patterns of celiac disease include intestinal and extraintestinal manifestations. serological patterns include total IgA level, tissue transglutaminase IgA \& IgG levels and endomesial IgA \& IgG levels. Endoscopic patterns include patchy or generalized atrophy and scalloping of duodenal mucosa. Pathological patterns include features of mucosal atrophy and modified Marsh classification.

    1 Year

Study Arms (1)

patterns of celiac disease in children

clinicopathological, endoscopic and serological patterns of celiac disease in children

Procedure: Upper GIT endoscopy

Interventions

upper GIT endoscopy of suspected cases and multiple biopsies will be taken for histopathological examination

Also known as: Upper endoscopy
patterns of celiac disease in children

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study will include children who will be admitted to the department of pediatrics at Sohag University Hospital during the study period and which will be fulfilling the following eligibility criteria in addition to all children previously diagnosed with celiac disease in the last 1 years.

You may qualify if:

  • Children less than 18 years.
  • Both sexes.
  • Children suffering from manifestations of celiac disease.
  • Children previously diagnosed with celiac disease.

You may not qualify if:

  • cases more than 18 years.
  • Children diagnosed with other causes of malabsorption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University

Sohag, Sohag Governorate, 82524, Egypt

Location

MeSH Terms

Interventions

Gastroscopy

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
pediatrician

Study Record Dates

First Submitted

December 30, 2024

First Posted

January 20, 2025

Study Start

August 25, 2024

Primary Completion

March 3, 2025

Study Completion

March 30, 2025

Last Updated

April 9, 2025

Record last verified: 2025-04

Locations