Protocol summary

Summary
Helicobacter pylori infection has a significant role in peptic ulcer(stomach and duodenum) , gastric cancer (adenocarcinoma, Maltoma) and chronic gastritis . Urea Breathing Test (UBT) is easy, safe, noninvasive method , because of high accuracy , it's used for early detection and also is detection method for after treatment of H.pylori infection . With due attention to cases of false negative urea breath test following the use of PPI, we intended to study effect of citric acid to reduce false-negative cases , with this insight , the PPI decreases gastric acidity and caused to inhibitory effects on H. Pylori infection but citric acid increases gastric acidity . Dyspepsia patients referred to the gastroenterology clinic of Razi Hospital, which H. Pylori with one of the methods (UBT, RUT, Stool antigen, Histology, serology) is known, enter to this study. Firstly patient profile form , filled consent and inclusion criteria included : age ≥ 18 years , detection of Helicobacter pylori infection , start treatment with PPI and exclusion criteria included : the history of previous gastric surgery , antibiotics consumption during 4 weeks before the first UBT test or during the study period , participation in a clinical study during 30 days before the screening visit , other considerable clinical disorders that researcher postulates patient is not eligible , taking H2 blocker or PPI, 2 weeks before the study, pregnancy , history of recent peptic ulcer and esophagitis , prior therapy , history of chronic liver and renal disease are examined . Urea breath test was performed for all patients if be positive , patients are included in this study then 14-day treatment period for all runs . In 13-12 days, patients are divided into two groups : urea breath test is performed in group 1 with concurrent administration of 4g of citric acid and in group 2 done without administration of citric acid . Again on days 14-15th , urea breath test is done without citric acid in group 1 and with 4g citric acid in group 2 . The results of urea breath test are studied either parallel or before and after (cross) in both study groups .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201105221155N12
Registration date: 2011-08-14, 1390/05/23
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-08-14, 1390/05/23
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
Vince chancellor for research Guilan university of medical sciences
Expected recruitment start date
2011-06-22, 1390/04/01
Expected recruitment end date
2012-06-21, 1391/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of citric acid on UBT results in dyspeptic patients on PPI and positive H.Pylori
Public title
Evaluation of the effect of citric acid on UBT results in dyspeptic patients on PPI and positive H.Pylori
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: Age ≥ 18 years ; Signed a consent form ; Detection of Helicobacter pylori infection ; start treatment with PPI Exclusion criteria: The history of previous gastric surgery ; Antibiotics consumption during 4 weeks before the first UBT test or during the study period ; Participation in a clinical study during 30 days before the screening visit ; Other considerable clinical disorders that researcher postulates patient is not eligible Taking H2 blocker or PPI ; 2 weeks before the study, Pregnancy ; History of recent peptic ulcer and esophagitis ; Prior therapy ; History of chronic liver and renal disease
Age
From 18 years old to 100 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
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
Guilan University of Medical Sciences. Ethics Committee Gastrointestinal and Liver Diseases Research
Street address
Sardar Jangal Ave, Gastrointestinal and Liver Diseases Research Center, Razi Hospital, Rasht, Iran
City
Rasht
Postal code
955655-41488
Approval date
2011-05-26, 1390/03/05
Ethics committee reference number
160/ش

Health conditions studied

1

Description of health condition studied
dyspepsia
ICD-10 code
k30
ICD-10 code description
Indigestion

Primary outcomes

1

Description
Urease breath test with administration 4g of citric acid
Timepoint
2 days
Method of measurement
UBT

2

Description
Urease breath test without administration 4g of citric acid
Timepoint
2 days
Method of measurement
UBT

Secondary outcomes

empty

Intervention groups

1

Description
Group 1 : In during 12-13th days of PPI treatment , urease breath test is done with coadministration 4g of citric acid and in during 14-15th days it's done without administration of citric acid .
Category
Diagnosis

2

Description
Group 2 : In during 12-13th days of PPI treatment , urease breath test is done without administration of citric acid and in during 14-15th days it's done with administration of 4g of citric acid .
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Gastrointestinal clinic of Razi hospital
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
Bidar Taban Ariya (BTA)
Full name of responsible person
Mr. Ali Mohammad Rafat Zand
Street address
No.1831 , unit 37 , Kargare Shomali Avenue ,Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bidar Taban Ariya (BTA)
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.
City
Rasht
Postal code
95655-41448
Phone
+98 13 1553 5116
Fax
Email
F_Jokar@gums.ac.ir
Web page address
www.gldrc.org

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
Head / Full Professor of Internal Medicine & Gastroenterology
Other areas of specialty/work
Street address
Gastrointestinal and Liver Disease Research Center (GLDRC) , Razi hospital , Sardar Jangal Ave.
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
Dr. Maryam Bakhshandeh
Position
Researcher
Other areas of specialty/work
Street address
Gastrointestinal and Liver Disease Research Center (GLDRC) , Razi hospital , Sardar Jangal Ave.
City
Rasht
Postal code
41448-95655
Phone
+98 13 1553 5116
Fax
+98 13 1553 4951
Email
bmaryamb@yahoo.com
Web page address
www.gldrc.org

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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