NCT06371183

Brief Summary

A Comparative study of clinical, endoscopic and histopathological features of colitis in children

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
196

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Sep 2024

Typical duration for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress56%
Sep 2024Aug 2027

First Submitted

Initial submission to the registry

April 15, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2027

Last Updated

July 16, 2024

Status Verified

July 1, 2024

Enrollment Period

2 years

First QC Date

April 15, 2024

Last Update Submit

July 14, 2024

Conditions

Role of Ileoscopy in Diagnosis of Colitis

Outcome Measures

Primary Outcomes (1)

  • Is ileoscopy indicated for all children complaining of colitis on 196 patient

    Biopsy from ileum will be taken to diagnose colitis

    2years

Secondary Outcomes (1)

  • To correlate clinical manifestations by colonoscopic picture

    2years

Study Arms (1)

Patients with lower GI manifestations

OTHER

Patients with lower GI manifestations will undergo total colonoscopy with biopsy

Device: Colonoscope

Interventions

ColonoscopeDEVICE

Endoscopy for lower GIT

Patients with lower GI manifestations

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \. All patients diagnosed as colitis during the study period. 2. Age from 1 month to 18 years.

You may not qualify if:

  • Patients with lower gastrointestinal manifestations and weren't diagnosed as colitis during colonoscope.
  • Patients less than one month and more than 18 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Colonoscopes

Intervention Hierarchy (Ancestors)

Endoscopes, GastrointestinalEndoscopesDiagnostic EquipmentEquipment and SuppliesSurgical Equipment

Central Study Contacts

Asmaa Omar, MD

CONTACT

01003337028asmaaomar2749@gmail.com

Nagla Hassan Abufadan, Prof

CONTACT

0111 187 2237nagla.ibrahim@med.au.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Patients who complaining of lower GI manifestations
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
AOMSaid

Study Record Dates

First Submitted

April 15, 2024

First Posted

April 17, 2024

Study Start

September 1, 2024

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

August 30, 2027

Last Updated

July 16, 2024

Record last verified: 2024-07