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Comparison of effectiveness of four drugs: furazolidone, amoxicillin, bismuth, pantoprazole: with and without probiotic supplementation on eradication of helicobacter pylori in patients with dyspepsia

Protocol summary

Study aim
Determining a better approach for treatment of patients with dyspepsia
Design
The double blind randomized placebo-controlled clinical trial with independent groups, phase III, on 100 patients (50 in each group). For randomization, computer program will be used.
Settings and conduct
All patients will be visited by the physician, who recruits the patients into the study according to the inclusion and exclusion criteria. Based on the computer codes. The patients will be categorized into two groups and will receive the drugs in sealed packets without name.
Participants/Inclusion and exclusion criteria
Patients older than 18 years old, who referred with chronic dyspepsia to GI clinic of Loghman Hakim hospital, candidate of upper endoscopy without history of Helicobacter treatment, using antibiotics in the past four weeks, severe heart failure, renal failure, pulmonary failure, and renal failure were included
Intervention groups
Group A patients with dyspepsia receiving 4 drugs of furazolidone, amoxicillin, bismuth, and pantoprazole with probiotic Group B patients with dyspepsia receiving 4 drugs of furazolidone, amoxicillin, bismuth, and pantoprazole without probiotic
Main outcome variables
Response to treatment, adherence to treatment, and complications of drug regimens in the two groups

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200518047494N1
Registration date: 2020-06-12, 1399/03/23
Registration timing: registered_while_recruiting

Last update: 2020-06-12, 1399/03/23
Update count: 0
Registration date
2020-06-12, 1399/03/23
Registrant information
Name
Nafeh Noorbakhsh sabet
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4423 8325
Email address
nafeh.noorbakhsh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-06, 1398/09/15
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness of four drugs: furazolidone, amoxicillin, bismuth, pantoprazole: with and without probiotic supplementation on eradication of helicobacter pylori in patients with dyspepsia
Public title
effectiveness of probiotic supplementation on eradication of helicobacter pylori
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients older than 18 years, who referred for chronic dyspepsia to GI clinic of Loghman Hakim hospital, candidate for upper endoscopy
Exclusion criteria:
Patients with a history of eradication of Helicobacter pylori patients taking antibiotics during the past four weeks Patients with a history of severe heart failure Patients with a history of severe liver failure Patients with a history of severe pulmonary failure Patients with a history of severe renal failure
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly assignment of patients to one of two treatment groups: Group A, 14-day regimen with high-dose furazolidone and probiotic supplement Group B, 14-day regimen with high-dose furazolidone with placebo Randomization will be performed by computer program and the computer codes were specified to each patient, referred to pharmacy for getting drug or placebo.
Blinding (investigator's opinion)
Double blinded
Blinding description
Groups were determined by the code generated by computer program for each person and the patient is refered to the pharmacy with this code to receive drug or placebo.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Medicine College- Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Next to Taleghani Hospital, Shahid-Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-02-19, 1397/11/30
Ethics committee reference number
IR.SBMU.MSP.REC.1397.682

Health conditions studied

1

Description of health condition studied
dyspepsia
ICD-10 code
K30
ICD-10 code description
Functional dyspepsia

Primary outcomes

1

Description
response to treatment
Timepoint
Two weeks after the initiation of treatment
Method of measurement
Fecal antigen test

Secondary outcomes

1

Description
Adherence to treatment
Timepoint
Two weeks after initiation of treatment
Method of measurement
By counting the number of pills

2

Description
Adverse effects of the drugs
Timepoint
Two weeks after initiation of treatment
Method of measurement
Asking the patient

Intervention groups

1

Description
Intervention group: Treated with probiotic supplement in addition to 4-drug regimen
Category
Treatment - Drugs

2

Description
Control group: Treated with 4-drug regimen without probiotic supplement
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Loghman-Hakim Hospital
Full name of responsible person
Dr. Shahriyar Pournik
Street address
Loghman-Hakim Hospital, Special st., Lashkar ave., South Kargar St.
City
Tehran
Province
Tehran
Postal code
1333625445
Phone
+98 21 5541 9005
Email
loghman.hospital@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Shahriyar Pournik
Street address
Shahid Beheshti University of Medical Sciences, Next to Taleghani Hospital, Yemen St., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Medical college- Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nafeh Noorbakhsh Sabet
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
No.18, East Rezaie, Nahid st., Marzdaran St.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 4423 8325
Fax
Email
nafeh.noorbakhsh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nafeh Noorbakhsh Sabet
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
No.18, East Rezaie, Nahid st., Marzdaran St.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 4423 8325
Fax
Email
nafeh.noorbakhsh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nafeh Noorbakhsh Sabet
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
No.18, East Rezaie, Nahid st., Marzdaran St.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 4423 8325
Fax
Email
nafeh.noorbakhsh@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
Yes - There is 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
Title and more details about the data/document
We intend to publish the results of the study as a scientific article in valid journals.
When the data will become available and for how long
About a year
To whom data/document is available
It depends on the journal's policies
Under which criteria data/document could be used
It depends on the journal's policies
From where data/document is obtainable
the journal's website
What processes are involved for a request to access data/document
It depends on the journal's policies
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