Protocol summary

Study aim
Evaluation and therapeutic efficacy of Helicobacter pylori eradication protocol by adding each of the drugs simvastatin, probiotics and N-acetylcysteine (NAC)
Design
Individuals (162 patients) are divided into four groups of 42 in each group based on random permutations. Phase 2-3
Settings and conduct
Patients with positive helicobacter pylori infection in the gastroenterology clinic of Imam Hossein Hospital who meet the inclusion criteria. After collecting demographic, clinical and medical records or previous treatments, patients will be randomly assigned to one of four intervention groups: 1) four drugs (metronidazole, amoxicillin, pentaprazole and bismuth, 2) four drugs with probiotics yasimvastatin. or NAC for two weeks . Evaluation by stool antigen tests and Clinical signs one month after treatment
Participants/Inclusion and exclusion criteria
People over 18 years and under 65 years of age are non-pregnant and with positive stool or endoscopic antigen test for Helicobacter pylori without history of heart failure, kidney and liver failure, no diabetes, no active cancer, no drug and alcohol addiction, no history of receiving previous treatment and no recent history of gastrointestinal bleeding.
Intervention groups
After collecting baseline information including demographic characteristics, clinical manifestations, and previous medical or therapeutic records, patients were divided into four intervention groups: 1) The standard four-drug protocol receiving group (metronidazole 250 mg, amoxicillin 1000 mg, pentaprazole 40 mg and bismuth 120 mg) all twice a day, 2) the four-drug protocol receiving group with probiotics ( 250 mg daily), 3) four-drug protocol group with simvastatin (10 mg daily) and 4) four-drug protocol group with NAC (600 mg daily).
Main outcome variables
Comparison of Helicobacter pylori eradication in the study groups.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220406054431N1
Registration date: 2022-05-08, 1401/02/18
Registration timing: prospective

Last update: 2022-05-08, 1401/02/18
Update count: 0
Registration date
2022-05-08, 1401/02/18
Registrant information
Name
maryam mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7343 0000
Email address
886maryammohammadi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-10, 1401/02/20
Expected recruitment end date
2022-08-06, 1401/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the efficacy of quadruple standard regimen combined with simvastatin, probiotic, and NAC as adjuvant therapy for H. Pylori eradication and comparing to standard treatment
Public title
Effect of simvastatin, probiotic and NAC drugs as adjuvant therapy to standard treatment in the eradication of Helicobacter pylori
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People over the age of 18 and under 65 With positive stool antigen test or endoscopy for Helicobacter pylori
Exclusion criteria:
History of heart, kidney and liver failure Diabetes Developing an active cancer Drug and alcohol addiction Recent history of gastrointestinal bleeding Get previous treatment
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 168
Randomization (investigator's opinion)
Randomized
Randomization description
According to the method of permutation blocks, 8 people are divided into 2 groups completely randomly.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Chamran Highway, Yemen Street, Student Boulevard next to Taleghani Hospital
City
Tehran
Province
Tehran
Postal code
1985717434
Approval date
2020-03-10, 1398/12/20
Ethics committee reference number
IR.SBMU.MSP.REC.1398.1001

Health conditions studied

1

Description of health condition studied
Helicobacter pylori infection
ICD-10 code
B96.81
ICD-10 code description
Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere

Primary outcomes

1

Description
Helicobacter pylori eradication rate
Timepoint
Beginning of the study and one month later
Method of measurement
Stool test for Helicobacter pylori antigen

Secondary outcomes

empty

Intervention groups

1

Description
The standard four-drug protocol recipient group (metronidazole kimidaro 250 mg, amoxicillin-producing 1000 mg, pentaprazole kimidaro 40 mg and bismuth kimidaro 120 mg) all twice daily for 2 weeks.
Category
Treatment - Drugs

2

Description
Intervention group: standard four drugs plus oral probiotic famiLact zist takhmir (250 mg daily) for 2 weeks.
Category
Treatment - Drugs

3

Description
Intervention group: standard four drugs plus simvastatin Poursina (10 mg daily) for 2 weeks.
Category
Treatment - Drugs

4

Description
Intervention group:standard four drugs plus n-acetylcysteine ​​Avesina (600 mg daily) for 2 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein hospital
Full name of responsible person
Maryam Mohammadi
Street address
Imam Hossein hospital, Shahid Madani Street
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
info@ehmc.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zaraghi
Street address
Building No. 2, Shahid Arabi St., Yemen St., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9788
Email
urm@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice-chancellor in research affairs of 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
Elena Lak
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Hossein hospital, Shahid Madani Street
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
dr_elenalak@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Majid Iranshahi
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Hossein hospital, Shahid Madani Street
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
iranshahi.majid@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Mohammadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Imam Hossein hospital, Shahid Madani Street
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
886maryammohammadi@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
Undecided - It is not yet known if there will be 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
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