ClinicalTrials.gg
Status unknownNCT06558578Updated Aug 26, 2024

Association of Helicobacter Pylori Infection and Migraine

An interventional study of Helicobacter pylori antigen in stool in Migraine in Children, sponsored by Sohag University. Status unknown at 1 site in Egypt. Open to participants aged 6 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-26.

Sponsored by Sohag University · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Aug 2024), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
6 Years to 16 Years
Sex
All
01

Study summary

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

Read the detailed description

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 .

02

Conditions studied

  • Migraine in Children
03

In context

Lead sponsor

Sohag University is the lead sponsor of 1,220 studies on the registry; 629 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility 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.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    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.

    Diagnostic Test: Helicobacter pylori antigen in stool

  • Other
    Control

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

    Diagnostic Test: Helicobacter pylori antigen in stool

Interventions

  • Diagnostic testHelicobacter 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.

    Also known as: Upper gastrointestinal tract endoscopy

06

What researchers measure

Primary outcomes

  1. migraine in children and adolescent

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

    Time frame: Over 1 year

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2024 (actual). Primary completion is estimated for Jul 2025, 11 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 9, 2024
First posted
Aug 16, 2024
StartActual
Aug 1, 2024
Primary completionEst.
Jul 30, 2025
CompletionEst.
Aug 30, 2025
Last update
Aug 26, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06558578
Lead sponsor
Sohag University
Responsible party
Mohamed Ragab Ali (Principal investigator, Sohag University) — Principal investigator
First posted
Aug 16, 2024
Start date
Aug 1, 2024
Primary completion
Jul 30, 2025 (estimated)
Completion
Aug 30, 2025 (estimated)
Last update
Aug 26, 2024

Study contacts

Mohamed Ragab Ali
Contact
medo26101995@gmail.com
01112790878
mohamed ragab
Contact
medo26101995@gmail.com
01228434808
mohamed ragab
principal investigator · Mohamed Ragab

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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