Protocol summary
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Study aim
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The effect of Saccharomyces boulardii as an adjuvant therapy in the eradication of Helicobacter pylori
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Design
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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
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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Patients with Helicobacter pylori infection over 18 years of age referring to Shahid Beheshti Hospital in Kashan who have indication for treatment
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Intervention groups
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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)
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Main outcome variables
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Eradication of Helicobacter pylori (Stool Antibody test)
General information
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Reason for update
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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.
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Acronym
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IRCT registration information
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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
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Registration date
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2022-11-03, 1401/08/12
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-11-05, 1401/08/14
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Expected recruitment end date
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2023-03-06, 1401/12/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of Saccharomyces bulardii as an adjunctive therapy in the eradication of Helicobacter pylori
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Public title
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The effect of Saccharomyces bulardii in the eradication of Helicobacter pylori
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 19 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
152
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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).
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-09-11, 1401/06/20
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Ethics committee reference number
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IR.KAUMS.MEDNT.REC.1401.117
Health conditions studied
1
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Description of health condition studied
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Helicobacter pylori disease
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ICD-10 code
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B98
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ICD-10 code description
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Helicobacter pylori [H.pylori] as the cause of diseases classified to other chapters
Primary outcomes
1
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Description
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Helicobacter pylori eradication
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Timepoint
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After one month of the last dose of antibiotics, and the patients have not taken PPI drugs for at least two week
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Method of measurement
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Fecal antigen test
Intervention groups
1
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Description
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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)
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Category
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Treatment - Drugs
2
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Description
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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)
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available