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Assessment of efficacy of N-Acetylecysteine plus standard quadruple therapy regimen in comparison to standard quadruple therapy regimen for H. pylori infection eradiacation

Protocol summary

Summary
aim: if NAC is applied as an adjunct to standard therapy in H. pylori eradication, it may have an additive influence. design: clinical trial methods and materials: In this study, all patients with dyspepsia and with positive rapid urease test (RUT) will be enrolled. Patients randomized in one of two treatment groups: The experimental group was given amoxicillin (capsules, 1000 mg) bid (with breakfast and dinner), clarithromycin (capsules, 500 mg) bid (with breakfast and dinner), and omeprazole (capsules, 20 mg) bid (before breakfast and dinner), plus NAC 600 mg bid. The control group was given amoxicillin/clarithromycin/omeprazole the same as experimental group, plus placebo. In patients without peptic ulcer, omeprazole 20 mg once daily was continued for 2 weeks. But patients with peptic ulcer were treated for 4–6 additional weeks. Exclusion criteria: age<18 and >70, recent use of antibiotics, bismuth salts, or proton pump inhibitors (PPI), chronic use of nonsteroidal anti-inflammatory drugs or corticosteroids, gastric outlet obstruction, pregnancy, renal failure, gastric malignancy, and prior gastric surgery

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201605201155N24
Registration date: 2016-08-30, 1395/06/09
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-08-30, 1395/06/09
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
vice chancellor for Research of Guilan University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of efficacy of N-Acetylecysteine plus standard quadruple therapy regimen in comparison to standard quadruple therapy regimen for H. pylori infection eradiacation
Public title
Assessment of efficacy of N-Acetylecysteine plus standard quadruple therapy regimen in comparison to standard quadruple therapy regimen for H. pylori infection eradiacation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients with peptic-like epigastric pain and dyspeptic symptoms, referred to the endoscopy unit and scheduled for upper GI endoscopy and with positive rapid urease test Exclusion criteria: age<18 and >70, recent use of antibiotics, bismuth salts, or proton pump inhibitors (PPI), chronic use of nonsteroidal anti-inflammatory drugs or corticosteroids, gastric outlet obstruction, pregnancy, renal failure, gastric malignancy, and prior gastric surgery
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Gastrointestinal and Liver Disease Research Center of Guilan University of Medic
Street address
Gastrointestinal and Liver Diseases Research Center, Razi Hospital, Sardare Jangal Avenue, Rasht, Guilan province, Iran
City
Rasht
Postal code
4144895655
Approval date
2015-07-21, 1394/04/30
Ethics committee reference number
812

Health conditions studied

1

Description of health condition studied
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
eradocation of Helicobacter pylori
Timepoint
before initiate Intervention, two wk after finishing the intervention
Method of measurement
Urease breath test

Secondary outcomes

1

Description
side effects
Timepoint
before initiating intervention, 2 wk after finishing the intervention
Method of measurement
physical examination

Intervention groups

1

Description
The experimental group was given amoxicillin (capsules, 1000 mg) bid (with breakfast and dinner), clarithromycin (capsules, 500 mg) bid (with breakfast and dinner), and omeprazole (capsules, 20 mg) bid (before breakfast and dinner), plus NAC 600 mg bid.
Category
Treatment - Drugs

2

Description
(The control group was given amoxicillin/clarithromycin/omeprazole the same as experimental group, plus placebo.In patients without peptic ulcer, omeprazole 20 mg once daily was continued for 2 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Gastrointestinal and Liver Diseases Research Center
Full name of responsible person
Farahnaz Joukar
Street address
Gastrointestinal and Liver Diseases Research Center, Razi Hospita, Sardare Jangal Avenue
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Guilan University of Medical Sciences
Full name of responsible person
Dr Rasool Tabari KHomeirani
Street address
Sadati Street, Namjoo Street, Rasht ,Guilan,Iran
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Guilan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Gastrointestinal and Liver Disease Research Center(GLDRC)
Full name of responsible person
Farahnaz Joukar
Position
Assistant of Gastrointestinal and Liver Disease Research Center (GLDRC)
Other areas of specialty/work
Street address
Gastrointestinal and Liver Disease Research Center (GLDRC), Razi Hospital, Sardar Jangal Ave, Guilan province, IRAN
City
Rasht
Postal code
Phone
+98 13133535116
Fax
Email
F_Jokar@gums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gastrointestinal and Liver Disease Research Center (GLDRC)
Full name of responsible person
Dr.Fariborz Mansour-Ghanaei
Position
Professor of Gastroenterology and Hematology Guilan, Chief of Gastrointestinal and Liver Disease Res
Other areas of specialty/work
Street address
Gastrointestinal and Liver Disease Research Center (GLDRC), Razi Hospital, Sardar Jangal Ave, Guilan province, Iran
City
Rasht
Postal code
Phone
+98 13 1553 5116
Fax
Email
ghanaei@gums.ac.ir
Web page address
www.gldrc.org

Person responsible for updating data

Contact
Name of organization / entity
Gastrointestinal and Liver Disease Research Center
Full name of responsible person
Sara Mavaddati
Position
Bachelor of Cellular & Molecular Biology
Other areas of specialty/work
Street address
Gastrointestinal and Liver Disease Research Center (GLDRC), Razi Hospital, Sardar Jangal Ave, Guilan province, IRAN
City
Rasht
Postal code
Phone
00
Fax
Email
Mavaddati.sara@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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