Assessment effect of Lactobacillus Reuteri (pyloshot) in H.pylori eradication with clarithromycin, amoxicillin and pantoprazole
Design
This study is a phase 3 parallel randomized clinical trial. . Individuals are told that they are randomly assigned to one of these two groups of 38 people.
Settings and conduct
In this study, the control group will receive standard and routine treatment consisting of two antibiotics (amoxicillin 1 gr twice daily and clarithromycin 500 mg twice daily), pantoprazole 40 mg twice daily, and placebo twice daily for two weeks. In the case group, in addition to standard treatment, pilots are prescribed for two weeks. In this study, patients in the case group used calcium, magnesium and zinc in the form of pilot capsules in addition to Lactobacillus and Bifidobacterium probiotics.
The outcome of this study is the presence of Helicobacter pylori, which is measured by the treatment success index. Outcomes of treatment 4 weeks after treatment, the rate of bacterial eradication in both groups is evaluated. The success rate of treatment is assessed by screening for Helicobacter pylori antigen and the rate is assessed by a stool test.
Participants/Inclusion and exclusion criteria
1- Have Helicobacter pylori.
2- The patient volunteering to participate in the study,
3- Age 40-75 years
4- Be a resident of Arak.
Intervention groups
In the case group, in addition to standard treatment (amoxicillin 1 gr twice daily and clarithromycin 500 mg twice daily and pentoprazole 40 mg twice daily) for two weeks, Lactobacillus and Bifidobacterium probiotic capsules are used twice daily. In this study, the control group will receive standard and national treatment (amoxicillin 1 gr twice daily, clarithromycin 500 mg twice daily, and pantoprazole 40 mg twice daily) with placebo twice daily for two weeks.
Main outcome variables
Eradication of Helicobacter pylori infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201225049825N1
Registration date:2021-02-12, 1399/11/24
Registration timing:registered_while_recruiting
Last update:2021-02-12, 1399/11/24
Update count:0
Registration date
2021-02-12, 1399/11/24
Registrant information
Name
Zahra Hashemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3368 3717
Email address
drhashemiz2018@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-06-22, 1400/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment effect of Lactobacillus Reuteri (pyloshot) in H.pylori eradication with clarithromycin, amoxicillin and pantoprazole
Public title
Evaluation of the effect of Lactobacillus ruteri in the treatment of Helicobacter pylori with clarithromycin, pantoprazole and amoxicillin regimen
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Have Helicobacter pylori
The patient volunteering to participate in the study,
Age 40-75 years
Be a resident of Arak.
Exclusion criteria:
Having a metastatic cancer
Pregnancy
Breastfeeding
History of failure of previous H.PYLORI treatment
Incomplete prescribed treatment regimen
Irregular use of medications and non-adherence to the prescribed treatment regimen
Previous gastrectomy
Suffering from incurable diseases
Patients with IHD
Chronic renal failure
GI bleeding
Malignancy
Concomitant use of tetracycline, quinolone, bisphosphonates, and levothyroxine (drug interaction)
People undergoing chemotherapy
Short Bowel Syndrome
Anemia and neutropenia
fever
History of drug and food allergies
Hypercalcemia
Age
From 40 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, individuals were divided into groups by block blinding method so that first 4 blocks were prepared as AABB and ABAB, ABBA, BBAA, BABA, BAAB and then these blocks were randomly arranged and individuals According to A and B, they were assigned to two groups and this was repeated continuously.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind study. Blinding will be done for both participants and the researcher using the same appearance of the drugs, which will be done by the drug company.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
University of Medical Sciences, Payambar Azam University Complex. Deputy of research and technology
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2020-09-16, 1399/06/26
Ethics committee reference number
IR.ARAKMU.REC.1399.175
Health conditions studied
1
Description of health condition studied
Helicobacter pylori infection
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Helicobacter pylori infection using fecal antigen test
Timepoint
At the beginning of the study and 4 weeks after the intervention
Method of measurement
Stool antigen test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, in addition to the standard and routine treatment , which includes two antibiotics (amoxicillin one gram twice a day and clarithromycin five hundred mg twice a day) and pantoprazole 40 mg twice a day, pilochat is prescribed for two weeks. In this study, patients in the experimental group used calcium, magnesium and zinc in the form of pilot capsules in addition to Lactobacillus and Bifidobacterium probioticsprobiotics.
Category
Treatment - Drugs
2
Description
Control group: In this study, the control group will receive standard treatment (amoxicillin 1 gr twice daily, clarithromycin 500 mg twice daily, and pantoprazole 40 mg twice daily) with placebo twice daily for two weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Al-Momenin Hospital, Arak
Full name of responsible person
Zahra Hashemi
Street address
Amir Al-Momenin Hospital, Next to the School of Medicine, Basij Square (Sardasht), Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3601
Email
it-amiralmomenin@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Finance Management, Third Floor, Arak University of Medical Sciences, Alma Al-Huda St., Shahid Shiroodi St.
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3312 4955
Email
dopdarman@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Zahra Hashemi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Laleh Alley 8, Hafezieh Boulevard, Hafezieh Town
City
Arak
Province
Markazi
Postal code
۳۸۱۸۶۶۵۵۶۷
Phone
+98 86 3368 3717
Email
Drhashemiz2018@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Zahra.Hashemi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Laleh Alley 8, Hafezieh Boulevard, Hafezieh Town
City
Arak
Province
Markazi
Postal code
۳۸۱۸۶۶۵۵۶۷
Phone
+98 86 3368 3717
Email
Drhashemiz2018@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
zahra Hashemi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Laleh Alley 8, Hafezieh Boulevard, Hafezieh Town
City
Arak
Province
Markazi
Postal code
۳۸۱۸۶۶۵۵۶۷
Phone
+98 86 3368 3717
Email
Drhashemiz2018@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
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Students and researchers can use the data of this study.
From where data/document is obtainable
Researchers can contact the study author via email at Drhashemiz2018@gmail.com to receive data and information.
What processes are involved for a request to access data/document
Request information and data to the author via email Drhashemiz2018@gmail.com