Comparision of H.pylori eradication rate in quadriple regimen"Bismuth subcytrate,Pantazol,Amoxicillin, Formilid and Lactobacillus reuteri” with placebo.
Design
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.
Settings and conduct
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
Participants/Inclusion and exclusion criteria
Inclusion criteria: Positive H. Pylori in the endoscopy; Not receiving therapeutic regimen for treatment; People over the age of 9 years.
Non-inclusion criteria: Pregnant and breast feeding women; Gastric and esophageal malignancy; Cirrhosis; Heart and kidney failure; Diabetes,...
Intervention groups
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.
Main outcome variables
H.pylori eradication
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080901001155N32
Registration date:2020-05-31, 1399/03/11
Registration timing:registered_while_recruiting
Last update:2020-05-31, 1399/03/11
Update count:1
Registration date
2020-05-31, 1399/03/11
Registrant information
Name
Farahnaz Joukar
Name of organization / entity
Guilan University of Medical Sciences, Gastrointestinal and liver disease Research Center
Country
Iran (Islamic Republic of)
Phone
+98 13 1553 5116
Email address
info@gldrc.org
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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.
Public title
The effect of quadriple regimen on the eradication rate of Helicobacter pylori
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Positive Helicobacter pylori in the endoscopy
No therapeutic regimen for treatment
People over the age of 9 years (because of the Probiotic used in children over the age of 9 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
Age
From 9 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
420
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
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
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Guilan University of Medical Sciences.
Street address
Research and Technology Deputy ,Shaheed Beheshti street,Gaz square
City
Rasht
Province
Guilan
Postal code
41448956655
Approval date
2019-12-21, 1398/09/30
Ethics committee reference number
IR.GUMS.REC.1398.437
Health conditions studied
1
Description of health condition studied
En Helicobacter pylori
ICD-10 code
B98.0
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
8 weeks after the end of the treatment
Method of measurement
En Ureas Breath Test with C14
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: 14-day quadruple regimen including "Bismuth subcitrate manufactured by Kamidaroo 240 mg 2 times daily, pantazol 40 mg twice daily by Nicomed, 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
Category
Treatment - Drugs
2
Description
Intervention group 2: 14-day quadruple regimen including "Bismuth subcitrate manufactured by Kamidaroo 240 mg 2 times daily, Pantazol produced by Nicomed 40 mg twice daily, amoxicillin produced by Kosar company 1 gr twice daily, Formilid 500 mg manufactured by Actover" and Placebo
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Caspian Digestive Disease Research Center-Gastrointestinal and Liver Disease Research Center-GI Canc
Full name of responsible person
Dr.Fariborz Mansour-Ghanei
Street address
Sardar Jangal Ave, Gastrointestinal and Liver Diseases Research Center, Razi Hospital, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
95655-41448
Phone
+98 13 3353 5116
Fax
+98 13 3353 4951
Email
ghanaie@yahoo.com
2
Recruitment center
Name of recruitment center
Gastrointestinal and Liver Disease Research Center
Full name of responsible person
Dr.Fariborz Mansour-Ghanei
Street address
Gastrointestinal and Liver Diseases Research Center, Razi Hospita, Sardar Jangal Ave, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
95655-41448
Phone
+98 13 3353 5116
Fax
+98 13 3353 4951
Email
ghanaie@yahoo.com
3
Recruitment center
Name of recruitment center
GI Cancer Screening and Prevention Research Center
Full name of responsible person
Dr.Fariborz Mansour-Ghanei
Street address
Gastrointestinal and Liver Diseases Research Center, Razi Hospita, Sardar Jangal Ave, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
41448-95655
Phone
+98 13 3353 5116
Fax
+98 13 3353 4951
Email
ghanaie@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr.Mir saeed attarchi
Street address
Sadati st, Samjoo st, Rasht,Guilan
City
Rasht
Province
Guilan
Postal code
955655-41448
Phone
+98 13 3334 6489
Fax
+98 13 3333 3125
Email
msattarchi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Dr.Fariborz Mansour-Ghanei
Position
Full Professor of Internal Medicine & Gastroenterology
Latest degree
Subspecialist
Other areas of specialty/work
Specialist in gastrointestinal and liver diseases
Street address
Gastrointestinal and Liver Diseases Research Center, Razi Hospita, Sardar Jangal Ave, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
95655-41448
Phone
+98 13 3353 5116
Email
ghanaie@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr. Farahnaz Joukar
Position
Deputy of Gastrointestinal and Liver Diseases Research Center
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Gastrointestinal and Liver Diseases Research Center, Razi Hospita, Sardar Jangal Ave, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
95655-41448
Phone
+98 13 3353 5116
Email
ghanaie@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mehrnaz Asgharnezhad
Position
Master of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Gastrointestinal and Liver Diseases Research Center, Razi Hospita, Sardar Jangal Ave, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
955655-41448
Phone
+98 13 3353 5116
Email
asgharnezhad98@yahoo.com
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
The main outcome of this study, which is eradication of Helicobacter pylori, will be made available to the general public
When the data will become available and for how long
One year after printing results
To whom data/document is available
Researchers at relevant research centers, universities, and related doctors
Under which criteria data/document could be used
In this case, the decision has not yet been taken
From where data/document is obtainable
Mehrnaz Asgharnezhad Gastrointestinal and Liver Diseases Research Center, Razi hospital, Rasht 00981333535116, 955655-41448 asgharnezhad98@yahoo.com
What processes are involved for a request to access data/document
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