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IRCT20080901001155N32 IRCT 2020-05-31 Rasht University of Medical Sciences The effect of quadriple regimen on the eradication rate of Helicobacter pylori 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. 2019-12-22 anticipated 420 Complete https://irct.ir/trial/44733 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: 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. 3 En Helicobacter pylori. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: The main outcome of this study, which is eradication of Helicobacter pylori, will be made available to the general public When: One year after printing results To whom: Researchers at relevant research centers, universities, and related doctors Conditions: In this case, the decision has not yet been taken Where to obtain: Mehrnaz Asgharnezhad Gastrointestinal and Liver Diseases Research Center, Razi hospital, Rasht 00981333535116, 955655-41448 asgharnezhad98@yahoo.com How to obtain: 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 Comments:
public Dr.Fariborz Mansour-Ghanei
Gastrointestinal and Liver Diseases Research Center, Razi Hospita, Sardar Jangal Ave, Rasht, Iran
Rasht Iran (Islamic Republic of) 95655-41448 +98 13 3353 5116 ghanaie@yahoo.com Rasht University of Medical Sciences scientific Dr. Farahnaz Joukar
Gastrointestinal and Liver Diseases Research Center, Razi Hospita, Sardar Jangal Ave, Rasht, Iran
Rasht Iran (Islamic Republic of) 95655-41448 +98 13 3353 5116 ghanaie@yahoo.com Rasht University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Positive Helicobacter pylori in the endoscopy No therapeutic regimen for treatment People over the age of 18 years 18 years no limit Both 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 B98.0 Helicobacter pylori [H.pylori] as the cause of diseases classified to other chapters Treatment - Drugs Treatment - Drugs 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 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 Helicobacter pylori eradication. Timepoint: 8 weeks after the end of the treatment. Method of measurement: En Ureas Breath Test with C14. Rasht University of Medical Sciences Approved 2019-12-21 Ethics Committee of Guilan University of Medical Sciences. Research and Technology Deputy ,Shaheed Beheshti street,Gaz square Rasht Guilan Iran (Islamic Republic of)