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General information
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According to most of the studies and Harrison's book (internal medicine reference), it is recommended to check the eradication of Helicobacter pylori after two weeks of finishing PPI drugs. Therefore, in the measurement time section, the interval between the end of the PPI drug and checking the eradication of Helicobacter pylori from one week changed to two weeks. It should be noted that sampling has not been done yet.
According to most of the studies and Harrison's book (internal medicine reference), it is recommended to check the eradication of Helicobacter pylori after two weeks of finishing PPI drugs. Therefore, in the measurement time section, the interval between the end of the PPI drug and checking the eradication of Helicobacter pylori from one week changed to two weeks. It should be noted that sampling has not been done yet.
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با توجه به اکثر مطالعات و کتاب هاریسون (رفرنس طب داخلی) توصیه به بررسی ریشه کنی هلیکوباکتر پیلوری پس از دو هفته از اتمام داروهای دسته PPI شده است لذا در قسمت مقاطع زمانی اندازهگیری، فاصله بین اتمام داروی PPI و بررسی ریشه کنی هلیکوباکتر پیلوری از یک هفته به دو هفته تغییر یافت. لازم به ذکر است هنوز نمونه گیری انجام نشده است.
با توجه به اکثر مطالعات و کتاب هاریسون (رفرنس طب داخلی) توصیه به بررسی ریشه کنی هلیکوباکتر پیلوری پس از دو هفته از اتمام داروهای دسته PPI شده است لذا در قسمت مقاطع زمانی اندازهگیری، فاصله بین اتمام داروی PPI و بررسی ریشه کنی هلیکوباکتر پیلوری از یک هفته به دو هفته تغییر یافت. لازم به ذکر است هنوز نمونه گیری انجام نشده است.
Primary outcomes
#1
After one month of the last dose of antibiotics, and the patients have not taken PPI drugs for at least one week
After one month of the last dose of antibiotics, and the patients have not taken PPI drugs for at least two week
After one month of the last dose of antibiotics, and the patients have not taken PPI drugs for at least onetwo week
پس از یک ماه از گذشت آخرین دوز آنتی بیوتیک و همچنین بیماران حداقل یک هفته، داروهای دسته PPI را مصرف نکرده باشند
پس از یک ماه از گذشت آخرین دوز آنتی بیوتیک و همچنین بیماران حداقل دو هفته، داروهای دسته PPI را مصرف نکرده باشند
پس از یک ماه از گذشت آخرین دوز آنتی بیوتیک و همچنین بیماران حداقل یکدو هفته، داروهای دسته PPI را مصرف نکرده باشند
Protocol summary
Study aim
The effect of Saccharomyces boulardii as an adjuvant therapy in the eradication of Helicobacter pylori
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 152 patients, randomization list through www. sealedenvelope.com/simple-randomiser/v1/lists
Settings and conduct
Patients with Helicobacter pylori infection referred to Shahid Beheshti hospital clinic in Kashan will be randomly divided to receive standard four-drug treatment + Saccharomyces boulardii probiotic or standard four-drug treatment for a period of two weeks.
Participants/Inclusion and exclusion criteria
Patients with Helicobacter pylori infection over 18 years of age referring to Shahid Beheshti Hospital in Kashan who have indication for treatment
Intervention groups
Intervention group: treated for fourteen days with a regimen of four drugs (pantaprazole 40 mg twice a day + amoxicillin 1 gram twice a day + clarithromycin 500 mg twice a day + bismuth 240 mg twice a day) + Saccharomyces Boulardii probiotic with the Sabolar brand (in the form of 250 mg capsules twice a day)
Control group: for fourteen days treated with a four-drug regimen (pantaprazole 40 mg twice a day + amoxicillin 1 gram twice a day + clarithromycin 500 mg twice a day + bismuth 240 mg twice a day)
Main outcome variables
Eradication of Helicobacter pylori (Stool Antibody test)
General information
Reason for update
According to most of the studies and Harrison's book (internal medicine reference), it is recommended to check the eradication of Helicobacter pylori after two weeks of finishing PPI drugs. Therefore, in the measurement time section, the interval between the end of the PPI drug and checking the eradication of Helicobacter pylori from one week changed to two weeks. It should be noted that sampling has not been done yet.
Acronym
IRCT registration information
IRCT registration number:IRCT20221025056290N1
Registration date:2022-11-03, 1401/08/12
Registration timing:prospective
Last update:2023-02-09, 1401/11/20
Update count:1
Registration date
2022-11-03, 1401/08/12
Registrant information
Name
Vahid Kashanian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5541 0386
Email address
kashanian-v@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-05, 1401/08/14
Expected recruitment end date
2023-03-06, 1401/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Saccharomyces bulardii as an adjunctive therapy in the eradication of Helicobacter pylori
Public title
The effect of Saccharomyces bulardii in the eradication of Helicobacter pylori
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with Helicobacter pylori infection
Exclusion criteria:
History of systematic and standardized eradication treatment
Kidney failure
Taking antibiotics in the last month
The person is pregnant and breastfeeding
history of neurological disease
Weakness in the immune system or taking immunosuppressive drugs
Age
From 19 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
152
Randomization (investigator's opinion)
Randomized
Randomization description
First, the intervention group was coded with the letter A and the control group with the letter B, and then using the website www. sealedenvelope.com/simple-randomiser/v1/lists randomization list was prepared by selecting a sample size of 152 (two groups of 76) and permuted block randomization method (block size=4) (38 blocks of 4). Then, through the obtained randomization list, the subjects included in the study will be assigned to one of the two groups, A or B. For example, suppose that in the first four blocks, the permutation method is ABBA, so the first and fourth samples will be assigned to group A and the second and third samples to group B, and the same will continue until the last sample (152nd person).
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 Kashan University of Medical Sciences
Street address
Qutb Ravandi Boulevard - Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2022-09-11, 1401/06/20
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1401.117
Health conditions studied
1
Description of health condition studied
Helicobacter pylori disease
ICD-10 code
B98
ICD-10 code description
Helicobacter pylori [H.pylori] as the cause of diseases classified to other chapters
Primary outcomes
1
Description
Helicobacter pylori eradication
Timepoint
After one month of the last dose of antibiotics, and the patients have not taken PPI drugs for at least two week
Method of measurement
Fecal antigen test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For fourteen days, he was treated with a four-drug regimen (pantaprazole 40 mg twice a day + amoxicillin 1 gram twice a day + clarithromycin 500 mg twice a day + bismuth 240 mg twice a day) + Saccharomyces Boulardi probiotic under the Sabolar brand (in capsule form 250 mg twice daily)
Category
Treatment - Drugs
2
Description
Control group: For fourteen days, treated with a regimen of four drugs (pantaprazole 40 mg twice a day + amoxicillin 1 gram twice a day + clarithromycin 500 mg twice a day + bismuth 240 mg twice a day)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan Shahid Beheshti Hospital Clinic
Full name of responsible person
Vahid Kashanian
Street address
Qutb Ravandi Boulevard, Shahid Beheshti Hospital
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5558 9227
Email
beheshtihospital@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholamali Hamidi
Street address
Qutb Ravandi Blvd., University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5558 9399
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Vahid Kashanian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Diba 12 Ave., Sanat Blvd.
City
Kashan
Province
Isfehan
Postal code
8714893790
Phone
+98 31 5541 0386
Email
vhd2369@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Mohsen Razavizadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Qutb Ravandi Boulevard, Shahid Beheshti Hospital
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5558 9333
Email
mohsen_razavizadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Vahid Kashanian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Diba 12 Ave., Sanat Blvd.
City
Kashan
Province
Isfehan
Postal code
8714893790
Phone
+98 31 5541 0386
Email
vhd2369@gmail.com
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