A clinical trial comparing the effectiveness of probiotics along with standard three drug treatment and standard three drug treatment alone in eradicating Helicobacter pylori in dyspeptic patients between 15 and 45 years old with positive fecal antigen
Goal:the comparison of standard helicobacter pylori eradication regimen with and without using probiotics
Design
This study is a randomized clinical trial study. Subjects are told that they will be randomly assigned to one of these two 100-person groups.
Settings and conduct
In this study, which is carried out in the Madras hospital clinic, the control group of the standard treatment that includes antibiotics (amoxicillin 1 gram twice a day and clarithromycin 500 mg twice a day) and pantoprazole 40 mg twice a day and placebo twice a day for two will receive a week. In the control group, in addition to the standard treatment, lactocor is prescribed for two weeks. The outcome in this study is the presence of Helicobacter pylori, which is measured by the treatment success index. 4 weeks after the treatment, the amount of bacteria removal is evaluated through stool antigen test in both groups.
Participants/Inclusion and exclusion criteria
Entry criteria: age between 15-40 years; Verbal and written consent; symptoms of dyspepsia; Positive fecal Helicobacter pylori antigen test. Exclusion criteria: use of any antibiotic in the last 2 weeks; consumption of pump inhibitor during the last 1 month; History of any proven malignancy and history of receiving Helicobacter pylori eradication regimen at any time in the past
Intervention groups
In the test group, in addition to the standard treatment (amoxicillin 1 gram twice a day, clarithromycin 500 mg twice a day, and pantoprazole 40 mg twice a day), Lactobacillus and Bifidobacterium probiotic capsules are used for two weeks. In this study, the control group will receive standard and routine national treatment (amoxicillin 1 gram twice a day and clarithromycin 500 mg twice a day and pantoprazole 40 mg twice a day) along with placebo twice a day for two weeks.
Main outcome variables
Eradication of Helicobacter pylori infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221216056834N1
Registration date:2023-02-02, 1401/11/13
Registration timing:prospective
Last update:2023-02-02, 1401/11/13
Update count:0
Registration date
2023-02-02, 1401/11/13
Registrant information
Name
Ramin Talaie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2207 4100
Email address
r.talaie@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial comparing the effectiveness of probiotics along with standard three drug treatment and standard three drug treatment alone in eradicating Helicobacter pylori in dyspeptic patients between 15 and 45 years old with positive fecal antigen
Public title
The effectiveness of probiotics in eradicating Helicobacter pylori infection of the stomach
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 15-40 years
Verbal and written consent
symptoms of dyspepsia
Positive fecal Helicobacter pylori antigen test.
Exclusion criteria:
use of any antibiotic in the last 2 weeks
consumption of pump inhibitor during the last 1 month
History of any proven malignancy
history of receiving Helicobacter pylori eradication regimen at any time in the past.
Age
From 15 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, people are placed in groups using the block blinding method, so that first blocks of 4 are prepared in the form of AABB, ABAB, ABBA, BBAA, BABA, BAAB, and then these blocks are arranged randomly. And people are assigned to two groups according to A and B, and this work is repeated continuously. The website www.sealedenvelope.com is used to generate a random sequence for block randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is of double-blind type. Blinding for both the participants and the researcher will be done using the identical appearance of the drugs, which will be done by the drug manufacturing company.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Faculty of Medicine - Shahid Beheshti University of Medical Sciences (Research Ethics Committee)
Street address
Tehran - Velenjak - Shahid Beheshti University of Medical Sciences - Faculty of Medicine
City
tehran
Province
Tehran
Postal code
198396941
Approval date
2022-10-18, 1401/07/26
Ethics committee reference number
IR.SBMU.MSP.REC.1401.315
Health conditions studied
1
Description of health condition studied
Helicobacter pylori infection in dyspeptic patients
ICD-10 code
B96.81
ICD-10 code description
Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere
Primary outcomes
1
Description
Fecal antigen
Timepoint
one month after the end of the intervention
Method of measurement
elisa test
Secondary outcomes
1
Description
Digestive complications
Timepoint
1 month after the end of the intervention
Method of measurement
questionnaire
Intervention groups
1
Description
Control group: allocation of the standard treatment regimen alone (i.e. pentaprazole 40 mg (b.i.d), amoxicillin 1000 mg (b.i.d), clarithromycin 500 mg (b.i.d)) for 14 days along with a capsule similar to the probiotic capsule without any medicinal properties Made by a contracted pharmacist that is given exactly like probiotic capsules for 2 weeks from the start of the standard regimen.
Category
Treatment - Drugs
2
Description
Intervention group: treatment with three standard drugs (i.e., pentaprazole 40 mg (b.i.d), amoxicillin 1000 mg (b.i.d), clarithromycin 500 mg (b.i.d)) for 14 days along with probiotic capsules made by Bio Fermentation Company (Lactocer). Contains lactobacillus acidophilus and bifidobacterium bifidum, given twice a day from the day the treatment starts for up to 2 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Superspeciality Clinic of Modares Hospital in Tehran
Full name of responsible person
Ramin Talaie
Street address
End of Saadat Abad Street - Intersection of Imam Memorial Highway and Saadat Abad
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 23515
Fax
+98 21 2207 4101
Email
modarres@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Behrouz Abtahi
Street address
Tehran - Evin - Shahid Shahriari Square - Shahid Beheshti University Research and Technology Vice-Chancellor
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 29901
Email
pr-office@sbu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ramin Talaie
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Address: The end of Saadat Abad Street - the intersection of Imam Memorial Highway and Saadat Abad
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
021_23515
Email
r.talaie@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ramin Talaie
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Address: The end of Saadat Abad Street - the intersection of Imam Memorial Highway and Saadat Abad
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
021_23515
Email
modarres@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ramin Talaie
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Address: The end of Saadat Abad Street - the intersection of Imam Memorial Highway and Saadat Abad
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
021_23515
Email
r.talaie@sbmu.ac.ir
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 de-identifying individuals
When the data will become available and for how long
The 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 author of the study through r.talaie@sbmu.ac.ir to receive data and information.
What processes are involved for a request to access data/document
Researchers can contact the author of the study through r.talaie@sbmu.ac.ir to receive data and information.