Association of Helicobacter Pylori Infection and Migraine

NCT ID: NCT06558578

Last Updated: 2024-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Migraine is one of the most common types of headaches worldwide, affecting 12-15% of the world population, more common in women and also the main headache for which patients refer to specialist nerve clinics.

Migraine is a complex neurovascular condition involving vasodilatation of intracranial and extracerebral blood vessels. This results in activation of trigeminal sensory nervous pain pathway leading to headache. Serotonin and reserpine (serotonin evacuator) play a notable role in the development of migraine headache by increasing cerebral blood flow.

Migraine is characterized by episodic attack that may be moderate to severe in intensity, focal in nature, have a throbbing quality. Compared to adults, pediatric migraine is shorter in duration and often has bilateral, bifrontal in the point of location.

Migraine is divided into two main types of migraine are: migraine with aura in which patients experience transient visual or sensory symptoms (including flickering lights, spots, or pins that develop 5-20 minutes before attacks), occurring in approximately 25% of patients with migraine, and migraine without aura, occurring in the remaining 75% of patients .

Helicobacter pylori infection is a significant risk factor for migraine with no observational difference between two types (migraine with and without aura). Eradication treatment was helpful on the clinical improvement of pain.

H. pylori is a gram-negative, microaerophilic, spiral bacterium with increased motility by multiple unipolar flagella. It generates urease and colonizes the mucus layer adjacent to the gastric mucosa, usually being responsible for gastrointestinal impairments such as chronic active gastroenteritis, infection, gastric and duodenal ulcer, and, more rarely, stomach cancer, also may be the result of various extra-digestive conditions such as neurological, cardiovascular, metabolic, hematologic, ocular, or dermatological ones.

A research explained that gastrointestinal neuroendocrine cells such as enterochromaffin cells (EC cells) can synthesize and secrete serotonin (5-hydroxytryptamine; 5-HT) and some factors that motivate the cell to secrete 5-HT can cause central nervous system (CNS) perturbation via the brain-gut axis. Inflammation motivates the cell to secrete 5-HT e.g., when H. pylori infect a cell. Eradication of H. pylori infection has helpful outcomes to improve clinical attacks by the effect of eradication therapy on the inflammation induced high levels of 5-HT .

Other theory suggests that during the infection, superoxide radicals and NO are produced and prolonged oxidative injury caused by the persistent infection might be involved in regional cerebral flow changes during migraine .

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Migraine in Children

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cases

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.

Group Type ACTIVE_COMPARATOR

Helicobacter pylori antigen in stool

Intervention Type DIAGNOSTIC_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.

Control

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

Group Type OTHER

Helicobacter pylori antigen in stool

Intervention Type DIAGNOSTIC_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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Helicobacter pylori antigen in stool

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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Upper gastrointestinal tract endoscopy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

-Inclusion criteria: children between 6 and 16 years old. Both sexes. children who suffering from migraine.

-Exclusion Criteria: children below 6 years old\& children above 16 years old. Children suffering from epilepsy, Mental retardation, autism, attention deficient hyperactivity disorder.
Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sohag University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohamed Ragab Ali

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

mohamed ragab

Role: PRINCIPAL_INVESTIGATOR

Mohamed Ragab

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of medicine sohag university

Sohag, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mohamed Ragab Ali

Role: CONTACT

01112790878

mohamed ragab

Role: CONTACT

01228434808

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mohamed Ragab Ali

Role: primary

01112790878

Mohamed Ragab Ali

Role: backup

01228434808

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

soh-Med-27-07-14MS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Migraine Manager (R01)
NCT04567355 RECRUITING PHASE2