NCT06558578

Brief Summary

The study aims to assess the relation between migraine and H pylori infection in children and adolescent.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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 1, 2024

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 16, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

August 26, 2024

Status Verified

August 1, 2024

Enrollment Period

12 months

First QC Date

August 9, 2024

Last Update Submit

August 23, 2024

Conditions

Migraine in Children

Outcome Measures

Primary Outcomes (1)

  • migraine in children and adolescent

    assessment the association between migraine and H pylori infection in children and adolescent.

    Over 1 year

Study Arms (2)

Cases

ACTIVE COMPARATOR

Children with migraine (cases) Inclusion criteria Age: children between 6 and 16 years old. Both sexes. children who suffering from migraine. Exclusion criteria: Age: children below 6 years old\& children above 16 years old. Children suffering from epilepsy, Mental retardation, autism, attention deficient hyperactivity disorder.

Diagnostic Test: Helicobacter pylori antigen in stool

Control

OTHER

Healthy children (control) healthy children not suffering from migraine or any neurological diseases.

Diagnostic Test: Helicobacter pylori antigen in stool

Interventions

Helicobacter pylori antigen in stoolDIAGNOSTIC_TEST

H pylori antigen in stool: for all patients suffering from migraine and control group. Upper GIT endoscopy: for children with positive H Pylori antigen in stool.

Also known as: Upper gastrointestinal tract endoscopy
CasesControl

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine sohag university

Sohag, Egypt

RECRUITING

MeSH Terms

Interventions

DefecationEndoscopy, Digestive System

Intervention Hierarchy (Ancestors)

Digestive System Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • mohamed ragab

    Mohamed Ragab

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Ragab Ali

CONTACT

01112790878medo26101995@gmail.com

mohamed ragab

CONTACT

01228434808medo26101995@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 9, 2024

First Posted

August 16, 2024

Study Start

August 1, 2024

Primary Completion

July 30, 2025

Study Completion

August 30, 2025

Last Updated

August 26, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)