Determining the effect of H.pylori treatment regimen on improving pain and arthritis symptoms in patients with osteoarthritis
Design
The clinical trial with a control group, with parallel groups, without blinding and randomization, phase 3 will be completed on 60 patients.
Settings and conduct
60 patients with osteoarthritis referred to Hajar-Kashani Hospital-Imam Ali Clinic in Shehrkord will be included in the study. In addition to the common treatment of osteoarthritis, the H pylori positive group (intervention) will be given a Helicobacter pylori treatment regimen for 5 days. After 4 weeks from the start of the treatment, the eradication of Heliobacter is checked in order to classify the intervention group into two sub-groups, eradicated and not eradicated.8 weeks after the start of the treatment, the stability of the effect of Helicobacter pylori eradication on the improvement of arthritis symptoms and pain in patients with osteoarthritis will be investistigated in the intervention group where Helicobacter eradication has been proven.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age over 50 years; diagnosis of osteoarthritis according to x-ray, examination and clinical diagnosis of a specialist; presence of positive Helicobacter pylori infection; patient's consent to enter the study.
Exclusion criteria: presence of immunodeficiency disease, active cancer and other rheumatological diseases in the patient; recent use of antibiotics
Intervention groups
Intervention group: patients with osteoarthritis who are H pylori positivet-Receive standard treatment of osteoarthritis and H pylori treatment regimenControl group: patients with osteoarthritis who are H pylori negative-Receive standard treatment for osteoarthritis
Main outcome variables
Severity of Pain;disease activity;joint stiffness;quality of life;physical performance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231216060428N1
Registration date:2024-01-24, 1402/11/04
Registration timing:prospective
Last update:2024-01-24, 1402/11/04
Update count:0
Registration date
2024-01-24, 1402/11/04
Registrant information
Name
Ghazaleh Heidari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3222 0016
Email address
ghazaleh.heidari.1992@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-27, 1402/11/07
Expected recruitment end date
2024-04-18, 1403/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Helicobacter pylori treatment regimen on improving pain and arthritis symptoms in patients with osteoarthritis
Public title
Investigating the effect of Helicobacter pylori treatment regimen on osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 50 years
Osteoarthritis diagnosis according to the findings of the graphy, examination and Clinical diagnosis of a specialist doctor
Presence of positiveHelicobacter pylori infection based on endoscopy, fecal antigen test or serum antibody
Patient consent to enter the study
Exclusion criteria:
The presence of immunodeficiency disease, active cancer and other rheumatological diseases in the patient
lack of consent to participate and the patient's request to withdraw from the research plan
recent use of antibiotics
Age
From 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the School of Medicine,Shahrekord University of Medical Sciences
Street address
Headquarters of Shahrekord University of Medical Science,Kashani street.Shahrekord,Charmahal va Bakhtiari ,Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2024-01-03, 1402/10/13
Ethics committee reference number
IR.SKUMS.MED.REC.1402.076
Health conditions studied
1
Description of health condition studied
Osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Severity of Pain
Timepoint
Measurement of pain severity before the intervention and 4 and 8 weeks after the intervention
Method of measurement
WOMAC questionnaire, ten-point visual assessment of pain intensity (VAS), 5-question European quality of life (EQ-5D-3L)
2
Description
Joint stiffness
Timepoint
before the intervention and four and eight weeks after starting Helicobacter pylori treatment regimen
Method of measurement
WOMAC questionnaire
3
Description
Disease activity
Timepoint
before the intervention and four and eight weeks after starting Helicobacter pylori treatment regimen
Method of measurement
WOMAC questionnaire
4
Description
Quality of Life
Timepoint
before the intervention and Four and eight weeks after starting Helicobacter pylori treatment regimen
Method of measurement
Ten-point visual assessment of pain intensity (VAS), 5-question European quality of life (EQ-5D-3L)
5
Description
Physical performance
Timepoint
Measurement of Physical performance before the intervention and 4 and 8 weeks after the intervention
Method of measurement
WOMAC questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
IIntervention group: people suffering from osteoarthritis, whose presence of posituve Helicobacter pylori has been proven by endoscopy, fecal test or serology test. For this group, in addition to the common treatment of osteoarthritis, Helicobacter pylori treatment regimen includes: levofloxacin 500 mg per day from Abidi Pharmaceutical Company, amoxicillin 1 gram twice a day from Farabi Pharmaceutical Company and PPI (standard dose) twice a day from Abidi Pharmaceutical Company and tinidazole 500 mg twice a day Tehran Daru Pharmaceutical Company for 5 days is also give
Category
Treatment - Drugs
2
Description
Control group: People with osteoarthritis in whom Helicobacter pylori has been proven negative by endoscopy, fecal test or serology test
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar hospital/ Kashani hospital /Emam Ali clinic
Full name of responsible person
Ghazaleh Heidari Soodejani
Street address
Parastar street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3222 0016
Email
ghazaleh.heidari.1992@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Elham Reisi
Street address
Kashani street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3334 9507
Email
raeisi.e@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Ghazaleh Heidari Soodejani
Position
Resident of Internal Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Parastar street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3222 0016
Email
ghazaleh.heidari.1992@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Shahin Askari Savadjani
Position
Faculty of Assistant Professors
Latest degree
Subspecialist
Other areas of specialty/work
Rheumatology
Street address
Kashani street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3222 0016
Email
st_asgari.sh@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Ghazaleh Heidari Soodejani
Position
Resident of Internal Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Parastar street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3222 0016
Email
ghazaleh.heidari.1992@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
To share the data and documents of this research, only the information related to the main outcome will be shared. Also, files that can be published and do not violate people's privacy will be published.
When the data will become available and for how long
The access period will start 6 months after the results are published.
To whom data/document is available
Our data will only be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
If there are conditions, all our data will be shared except personal information of people. The use of our data will only be allowed for similar research and review of our data by other researchers. All those who work in universities and scientific centers and decide to conduct similar research or check the accuracy of our data can access our data
From where data/document is obtainable
In order to receive information, all eligible people can collect data by referring to the person in charge of the project. The contact methods are the email address ghazaleh.heidari.1992@gmail.com or the contact number 00989131889039
What processes are involved for a request to access data/document
To receive information after sending the request, the requests will be reviewed within 10 days. If the above conditions are met, the information will be sent to the provided email within 30 days at most.