Migraine in ChildrenNCT06558578
Association of Helicobacter Pylori Infection and Migraine
A study testing Helicobacter pylori antigen in stool in people with Migraine in Children, run by Sohag University at 1 site in Egypt.
Trial summary
The study aims to assess the relation between migraine and H pylori infection in children and adolescent. Read more about this study
- Who is it for?
- Ages 6 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine in Children
- What is being tested?
- Helicobacter pylori antigen in stool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
-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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine sohag university
Sohag
Mohamed Ragab Ali, 01112790878, medo26101995@gmail.com
Mohamed Ragab Ali, 01228434808, medo26101995@gmail.com
About this study
Official title: Association of Helicobacter Pylori Infection and Migraine in Children and Adolescent
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.
- 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
- Migraine in Children
- Being tested
- Helicobacter pylori antigen in stool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helicobacter pylori antigen in stoolDiagnostic test
Also called Upper gastrointestinal tract endoscopy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Helicobacter pylori antigen in stool |
| Control | Other | Healthy children (control) healthy children not suffering from migraine or any neurological diseases. Receives: Diagnostic Test: Helicobacter pylori antigen in stool |
What is being measured
The primary outcome is the main question the study is designed to answer.
migraine in children and adolescent
assessment the association between migraine and H pylori infection in children and adolescent.
Measured: Over 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start1 Aug 2024
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine in ChildrenStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ragab Ali, Sohag University
- Investigators
- mohamed ragab, Principal investigator, Mohamed Ragab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558578
- Sponsor's protocol ID
- soh-Med-27-07-14MS
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Helicobacter Pylori Infection and Migraine in Children and Adolescent
- ClinicalTrials.gov ID
- NCT06558578
- Acronym / sponsor ID
- soh-Med-27-07-14MS
- Conditions
- Migraine in Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 16 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to assess the relation between migraine and H pylori infection in children and adolescent.
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.
- 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 .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | Active comparator | Diagnostic Test: Helicobacter pylori antigen in stoolChildren 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. |
| Control | Other | Diagnostic Test: Helicobacter pylori antigen in stoolHealthy children (control) healthy children not suffering from migraine or any neurological diseases. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Helicobacter pylori antigen in stoolAlso: Upper gastrointestinal tract endoscopyH 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. | Diagnostic test | Cases, Control |
Primary outcome
migraine in children and adolescent
Time frame: Over 1 year
assessment the association between migraine and H pylori infection in children and adolescent.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mohamed ragab principal investigator
Mohamed Ragab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Helicobacter pylori antigen in stool in people with Migraine in Children, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Ragab Ali (01112790878, medo26101995@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
migraine in children and adolescent (time frame: Over 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.