The effect of Helicobacter Pylori eradication in improving the symptoms of migraine patients
Design
Before and after clinical trial without control group and without blinding, phase 2 on 35 patients
Settings and conduct
Patients with migraine without aura were diagnosed by a neurologist at the Ghaem Mashhad Hospital based on the IHS criteria.
At the beginning of the study, migraine attacks are evaluated using the MIDAS questionnaire, and patients with a MIDAS score greater than 6 are referred to a gastroenterologist.
Then, people with a positive Helicobacter Pylori fecal antigen test are included in the study. In addition to classic migraine treatment, all patients will receive a Helicobacter Pylori eradication regimen (3-drug regimen with amoxicillin 1000 mg every 12 hours, clarithromycin 500 mg every 12 hours, and omeprazole 20 mg every 12 hours for 2 weeks).
After 4 weeks from the end of the treatment, fecal antigen tests are performed again in order to check the eradication of Helicobacter.
Re-evaluation in terms of the number and severity of migraine attacks is done 3 months after the end of the treatment.
Patients will receive medical treatment with sumatriptan 50 mg tablets in case of an acute migraine attack.
Participants/Inclusion and exclusion criteria
Patients with migraine without aura were diagnosed by a neurologist based on the criteria of the International Headache Society (IHS) over 16 years old, suffering from migraine without aura, a positive Helicobacter pylori fecal antigen test and the ability of cooperation
Intervention groups
A Helicobacter Pylori eradication regimen will be given to the intervention group for 2 weeks
Main outcome variables
Assessment of migraine severity based on a questionnaire before and after Helicobacter Pylori treatment, assessment of the prevalence of Helicobacter Pylori in migraine patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241011063326N1
Registration date:2024-10-31, 1403/08/10
Registration timing:prospective
Last update:2024-10-31, 1403/08/10
Update count:0
Registration date
2024-10-31, 1403/08/10
Registrant information
Name
Hossein Alimardani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3727 7347
Email address
alimardanih4001@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-05, 1403/08/15
Expected recruitment end date
2025-02-19, 1403/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Helicobacter Pylori eradication on reducing the frequency, intensity and duration of headache attacks in migraine patients without aura
Public title
The Effect of Helicobacter Pylori Eradication on Migraine
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Migraine without aura according to IHS diagnostic criteria
Helicobacter Pylori fecal antigen positive test
Lack of control of migraine attacks despite the classic treatment of migraine (the MIDAS score is mostly equal to 6, which is performed by a neurologist)
Exclusion criteria:
Inability to cooperate
Consumption of alcohol, smoking and contraceptive drugs
Pregnancy
Age
From 16 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
35
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
No.15 , Majd 10 Ave., Majd Blvd., Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9184877370
Approval date
2024-03-03, 1402/12/13
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1402.510
Health conditions studied
1
Description of health condition studied
migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Severity score of migraine attacks in MIDAS questionnaire
Timepoint
The beginning of the study (before the start of the intervention), 3 months after completing the Helicobacter Pylori eradication regimen
Method of measurement
Migraine disability assessment questionnaire
Secondary outcomes
1
Description
The prevalence of Helicobacter Pylori in patients with migraine without aura
Timepoint
The beginning of the study (before the start of the intervention)
Method of measurement
Helicobacter Pylori fecal antigen test
2
Description
Eradication rate of Helicobacter Pylori in patients with migraine without aura after completion of treatment
Timepoint
4 weeks after the completion of the Helicobacter Pylori eradication regimen
Method of measurement
Helicobacter Pylori fecal antigen test
Intervention groups
1
Description
Intervention group: Helicobacter Pylori eradication regimen (3-drug regimen) with amoxicillin 1000 mg every 12 hours, clarithromycin 500 mg every 12 hours, and omeprazole 20 mg every 12 hours for 2 weeks will be given to all patients.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurology Clinic of Ghaem Hospital
Full name of responsible person
Mohammad shariati
Street address
Ahmedabad Ave, Ghaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0001
Email
b.ghaem@mums.ac.ir
Web page address
2
Recruitment center
Name of recruitment center
Gastroenterology Clinic of Ghaem Hospital
Full name of responsible person
Mitra Ahadi
Street address
Ahmedabad Ave, Ghaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0001
Email
b.ghaem@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Research assistant of Mashhad University of Medical Sciences
Street address
University Ave., in front of University 18, building number one of Mashhad University of Medical Sciences (Qureshi), second floor, Research and Technology Vice-Chancellor
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3843 7840
Email
sram@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hossein Alimardani
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
No.15 , Majd 10 Ave., Majd Blvd., Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9184877370
Phone
+98 51 3727 7347
Email
alimardanih4001@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mitra Ahadi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Unit 404 , Faraz Doctors Building , Koohsangi 9 Ave , Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9184877370
Phone
+98 51 3840 2463
Email
ahadim@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hossein Alimardani
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
No.15 , Majd 10 Ave., Majd Blvd., Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9184877370
Phone
+98 51 3727 7347
Email
Alimardanih4001@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available