1. Home
  2. Approved trials
  3. » فارسی

Effect of N-Acetyl cysteine on the success rate of H.pylori eradication

Protocol summary

Summary
H.pylori eradication (HP) is the most common chronic bacterial infection in humans. HP is a Gram-negative spiral Microaerophilic organism . This study will be done as clinical trial and the aim of this study was comparing the administration of NAC as a pre-treatment before starting eradication regimen HP with the control group in terms of success.The sample size given that the response to standard therapy in the treatment of Helicobacter pylori According to sources, was 115 samples for each group and a total of 230 samples were estimated. Groups of patients referred to the gastroenterology clinic and endoscopy will be selected. All patients with more than 20 years of participation in the plan who are positive for HP and has eradication indication and do not use the drugs effective on HP, were randomly divided into two treatment and control groups. The Patients will be evaluated who at the time of studying have an indication for eradication of H pylori eradication and has not previously received any eradication regimen., and they also have NAC consumption during the last month. Exclusion criteria included a history of gastrectomy, gastric cancer includes adenocarcinoma and lymphoma, previous allergic reaction to antibiotics (amoxicillin and clarithromycin), NAC and proton pump inhibitors For example (omeprazole), pregnant and lactating women, concurrent severe illness, phenyl ketoneuria, taking antibiotics or NAC now or in the past month and is patient's dissatisfaction. Patients will be randomly divided into two groups. the treatment group are pretreated with NAC for the 600 mg 2 times a day for a week and then standard triple therapy alone (amoxicillin 1000 mg 2 times a day, clarithromycin 500 mg two times daily and omeprazole 20 mg 2 times a day).The control group are treated with standard triple therapy . The level of response to treatment in each category are calculated and compared. Variables included age, gender, current smoking, alcohol consumption, eradication indication regimen and complications during and up to one week after treatment and response to treatment. Response to treatment (eradication of Helicobacter pylori) will be evaluated by stool antigen test for a month at the end of treatment and at least 2 weeks after discontinuation of proton pump inhibitors (PPI). The required data in both groups will be collected through interviews and tests.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012121511738N2
Registration date: 2016-05-17, 1395/02/28
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-05-17, 1395/02/28
Registrant information
Name
Kurosh Masnadi Shirazi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 7554
Email address
masnadik@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Tabriz University of Medical Sciences
Expected recruitment start date
2016-04-01, 1395/01/13
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of N-Acetyl cysteine on the success rate of H.pylori eradication
Public title
Effect of N-Acetyl cysteine on the success rate of H.pylori eradication
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients older than 20 years old, HP positive patients at the time of an injection molded pylori eradication indicated they have not previously received eradication regimen, the patients who have NAC in past month. Exclusion criteria: history of gastrectomy, gastric cancer includes adenocarcinoma, previous allergic reaction to antibiotics (amoxicillin and clarithromycin), NAC and proton pump inhibitors (omeprazole), pregnant and lactating women, concurrent severe illness, phenyl ketone Avery, taking antibiotics or NAC now or in the past month and is patient's dissatisfaction.
Age
From 20 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 230
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not 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 Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Postal code
Approval date
2016-02-20, 1394/12/01
Ethics committee reference number
TBZMED.REC.1394.1186

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
The success rate of H pylori eradication regimen
Timepoint
One month after treatment
Method of measurement
Test

Secondary outcomes

empty

Intervention groups

1

Description
the treatment group are pretreated with NAC groups underfor the 600 mg 2 times a day for a week and then standard triple therapy (amoxicillin 1000 mg 2 times a day, clarithromycin 500 mg two times daily and omeprazole 20 mg 2 times a day).
Category
Treatment - Drugs

2

Description
Control group treated with standard triple therapy (amoxicillin 1000 mg 2 times a day, clarithromycin 500 mg two times daily and omeprazole 20 mg 2 times a day) are placed.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic for Gastroenterology and Endoscopy Department of Imam Reza
Full name of responsible person
Dr.Said Mansouri
Street address
Department of Gastroenterology, Imam Reza Hospital, Gate University, Tabriz, East Azarbaijan
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Vice chancellor for Research of Tabriz University of Medical Sciences,Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
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 Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Korosh Masnadi Shirazi
Position
Gastroenterologist, Assistant Professor
Other areas of specialty/work
Street address
Department of Gastroenterology, Imam Reza Hospital, Gate University, Tabriz, East Azarbaijan
City
Tabriz
Postal code
Phone
+98 41 3337 3966
Fax
Email
Masnadik@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Korosh Masnadi Shirazi
Position
Gastroenterologist, Assistant Professor
Other areas of specialty/work
Street address
Department of Gastroenterology, Imam Reza Hospital, Gate University, Tabriz, East Azarbaijan
City
Tabriz
Postal code
Phone
+98 41 3337 3966
Fax
Email
MasnadiK@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Said Mansouri
Position
Gastroenterology Fellow
Other areas of specialty/work
Street address
Department of Gastroenterology, Imam Reza Hospital, Gate University, Tabriz, East Azarbaijan
City
Tabriz
Postal code
Phone
+98 413545885
Fax
Email
smansouri79@yahoo.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
Loading...