Protocol summary
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Study aim
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Comparision of H.pylori eradication rate in quadriple regimen"Bismuth subcytrate,Pantazol,Amoxicillin, Formilid and Lactobacillus reuteri” with placebo.
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Design
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The present study is a phase 3 randomized clinical trial.The subjects were divided into two groups of 210 people as Block randomization.420 subjects were studied using available sampling and in the form of Double Blind, which neither the patient nor the physician will know about the drug.
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Settings and conduct
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The study was performed as multi-center study at Caspian Digestive Disease Research Center, Gastrointestinal and liver Disease Research Center and GI Cancer Screening and Prevention Disease
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Positive H. Pylori in the endoscopy; Not receiving therapeutic regimen for treatment; People over the age of 18 years.
Non-inclusion criteria: Pregnant and breast feeding women; Gastric and esophageal malignancy; Cirrhosis; Heart and kidney failure; Diabetes,...
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Intervention groups
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Intervention group1: Treated with 14-day quadruple regimen including Bismuth subcytrate 240 mg 2 times daily, Pantazol 40 mg twice daily, Amoxicillin1 g 2 times daily, Formilid 500 mg and Lactobacillus reuteri 100 mg 2 times daily. The first two weeks they will be treated with probiotic with quadruple regimen and two weeks later only antibiotics .
Intervention group 2: Treated with 14-day quadruple regimen mentioned above with Placebo twice daily and only placebo will be given weekly that antibiotics will be given two weeks later. The first two weeks they will be treated with placebo with quadruple regimen and two weeks later only antibiotics.
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Main outcome variables
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H.pylori eradication
General information
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Reason for update
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Correction of inclusion criteria and correction of pharmaceutical company name
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20080901001155N32
Registration date:
2020-05-31, 1399/03/11
Registration timing:
registered_while_recruiting
Last update:
2021-05-02, 1400/02/12
Update count:
1
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Registration date
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2020-05-31, 1399/03/11
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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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2019-12-22, 1398/10/01
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Expected recruitment end date
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2020-08-22, 1399/06/01
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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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Comparision of H.pylori eradication rate in quadriple regimen " Bismuth subcytrate , Pantazol,Amoxicillin, Formilid and Probiotic(Lactobacillus reuteri)” with quadriple regimen " Bismuth subcytrate, Pantazol,Amoxicillin, Formilid and placebo.
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Public title
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The effect of quadriple regimen on the eradication rate 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:
Positive Helicobacter pylori in the endoscopy
No therapeutic regimen for treatment
People over the age of 18 years
Exclusion criteria:
Pregnant and breast feeding women
Gastric and esophageal malignancy
Cirrhosis and Diabetes
heart and kidney failure
History of seizure, hematologic diseases
Immune system deficiency
Drug sensitivity including Pentoprazole and Lactobacillus routeri
Patients with incomplete treatment
With acute gastrointestinal disease (such as acute diarrhea)
Chronic gastrointestinal disease (such as inflammatory bowel disease and celiac disease)
Kidney failure
Nervous disease and those who received antibiotics or acidblocking drugs 6 weeks ago
Use of nonsteroidal antiinflammatory drugs (NSAIDs) such as aspirin 3 weeks before treatment or in the past month for any reason
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Age
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From 18 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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- Participant
- Care provider
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Sample size
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Target sample size:
420
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Participants and Health care personnel will not be informed about the type of group therapy they have received.To do this,the placebo drug will be ordered exactly the same as the probiotic and will be available to these people
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Placebo
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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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2019-12-21, 1398/09/30
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Ethics committee reference number
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IR.GUMS.REC.1398.437
Health conditions studied
1
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Description of health condition studied
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En Helicobacter pylori
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ICD-10 code
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B98.0
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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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8 weeks after the end of the treatment
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Method of measurement
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En Ureas Breath Test with C14
Intervention groups
1
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Description
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Intervention group 1: 14-day quadruple regimen including "Bismuth subcitrate manufactured by Kamidaroo 240 mg 2 times daily, pantazol 40 mg twice daily by Nycomed, amoxicillin made by Kosar 1 g twice daily, Formilid 500 mg manufactured) Actover" and Probiotic Lacto Bacillus router 100 mg twice a day produced by bio-fermentation company
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Category
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Treatment - Drugs
2
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Description
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Intervention group 2: 14-day quadruple regimen including "Bismuth subcitrate manufactured by Kamidaroo 240 mg 2 times daily, Pantazol produced by Nycomed 40 mg twice daily, amoxicillin produced by Kosar company 1 gr twice daily, Formilid 500 mg manufactured by Actover" and Placebo
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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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Rasht 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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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The main outcome of this study, which is eradication of Helicobacter pylori, will be made available to the general public
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When the data will become available and for how long
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One year after printing results
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To whom data/document is available
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Researchers at relevant research centers, universities, and related doctors
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Under which criteria data/document could be used
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In this case, the decision has not yet been taken
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From where data/document is obtainable
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Mehrnaz Asgharnezhad Gastrointestinal and Liver Diseases Research Center, Razi hospital, Rasht 00981333535116, 955655-41448 asgharnezhad98@yahoo.com
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What processes are involved for a request to access data/document
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At the outset, the applicant will email and complete his or her full introduction of the organization and the purpose of obtaining this data and will request the relevant documents or files.Subsequently, the data files will be made available to the applicant within the time period stated by the relevant investigator
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Comments
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