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Therapeutic effect of the regiment of helicobacter pylori treatment on the improvement of pain and symptoms of arthritis in patients with rheumatoid arthritis

Protocol summary

Study aim
Determining the effect of Helicobacter pylori treatment regimen on improving pain and arthritis symptoms in patients with rheumatoid arthritis.
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
RA patients referred to Hajar Hospital, their severity of disease is mild to moderate, will be included in the study by the rheumatologist. The patients will be divided into intervention and control groups according to the presence of H. pylori infection. This study will be conducted without blinding. the H.pylori +group (intervention), receive common treatment of RA and H.pylori treatment (Levofloxacin 500 mg, amoxicillin 1 mg, tinidazole 500 mg and pantoprazole 40 mg every 12 hours for 5 days). After 4 weeks from the beginning of the treatment, the eradication of H.pylori is checked to classify into eradicated and not eradicated subgroups. finally, 8 weeks after the start of treatment, we check all of Main outcome variables In order to check the stability of the eradication effect of Helicobacter pylori.
Participants/Inclusion and exclusion criteria
Inclusion criteria: People with mild to moderate rheumatoid arthritis according to the EULAR /criteriaPresence of positive H pylori infection Exit criteria:/Patient non-cooperation/Severe rheumatoid arthritis and the use of biological drugs in the treatment of RA/Suffering from other systemic diseases that are caused by surgery on the digestive system, synovectomy, and pregnancy
Intervention groups
Intervention group: Rheumatoid arthritis patients with H. pylori infection Control group: Rheumatoid arthritis patients that h.pylori negative
Main outcome variables
Patients' pain level, disease activity score, number of tender joints, morning stiffness, number of swollen joints, serum level of ESR, CRP, quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231209060313N1
Registration date: 2024-01-10, 1402/10/20
Registration timing: prospective

Last update: 2024-01-10, 1402/10/20
Update count: 0
Registration date
2024-01-10, 1402/10/20
Registrant information
Name
Ardalan Memar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3337 0157
Email address
ardalanmemar@yahoo.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
Therapeutic effect of the regiment of helicobacter pylori treatment on the improvement of pain and symptoms of arthritis in patients with rheumatoid arthritis
Public title
Therapeutic effect of the regiment of helicobacter pylori treatment on the improvement of pain and symptoms of arthritis in patients with rheumatoid arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years Patients with mild to moderate rheumatoid arthritis diagnosed by EULAR criteria (under traditional treatment with DMARD) Willingness to participate in the clinical trial Presence of positive H pylori infection based on endoscopy, fecal antigen or serum antibody test No recent use of antibiotics Absence of immunodeficiency diseases and active cancer Having an indication for the treatment of Helicobacter pylori infection
Exclusion criteria:
The patient's unwillingness to participate in the clinical trial death of the patient Severe rheumatoid arthritis and the use of biological drugs in the treatment of RA Patients with other systemic diseases, who have gastrointestinal surgery, have an active gastric ulcer, or synovectomy in any major joint. pregnancy
Age
From 18 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 Sciences,Kashani Street, Shahrekord, Chaharmahal va Bakhtiary, 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.1402.077

Health conditions studied

1

Description of health condition studied
Rheumatoid arthritis
ICD-10 code
M05
ICD-10 code description
Rheumatoid arthritis with rheumatoid factor

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
Visual Analogue Scale (VAS) Questionnaire

2

Description
Disease activity
Timepoint
Measurement of Disease activity before the intervention and 4 and 8 weeks after the intervention
Method of measurement
DAS-28 Questionnaire

3

Description
Tender joints
Timepoint
Measurement of Tender joints before the intervention and 4 and 8 weeks after the intervention
Method of measurement
DAS-28 Questionnaire

4

Description
swollen joints
Timepoint
Measurement of swollen joints before the intervention and 4 and 8 weeks after the intervention
Method of measurement
DAS-28 Questionnaire

5

Description
Morning stiffness
Timepoint
Measurement of morning stifness before the intervention and 4 and 8 weeks after the intervention
Method of measurement
DAS-28 Questionnaire

6

Description
Serum level of C-reactive protein
Timepoint
Measurement of Serum level of C-reactive protein before the intervention and 4 and 8 weeks after the intervention
Method of measurement
Measurement Serum level of C-reactive protein with a Flame Photometer

7

Description
Serum level of ESR
Timepoint
Measurement of Serum level of ESR before the intervention and 4 and 8 weeks after the intervention
Method of measurement
Measurement of serum ESR level with a Flame Photometer

8

Description
Quality of life
Timepoint
Measuring different aspects of quality of life before the intervention and 4 and 8 weeks after the intervention
Method of measurement
HAQ , EQ-5D Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: patients with rheumatoid arthritis whose presence of Helicobacter pylori has been proven by endoscopy or stool test or positive Helicobacter pylori serology test.
Category
Treatment - Drugs

2

Description
Control group: patient with rheumatoid arthritis in whose Helicobacter pylori has been proven negative by endoscopy or fecal test or negative serology test.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahrekord Hajar hospital
Full name of responsible person
Ardalan Memar
Street address
parastar street
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 913 929 1792
Email
ardalanmemar@yahoo.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
Parastar street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 913 929 1792
Email
ardalanmemar@yahoo.com
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
Ardalan Memar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
parastar street
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
ardalanmemar@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Shahin Asgari
Position
Rheumatologist
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Parastar street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
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
Ardalan Memar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Parastar street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
ardalanmemar@yahoo.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 ardalanmemar@yahoo.com or the contact number 00989139291792
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.
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