Effect of helicobacter pylori eradication regimen versus standard treatment on gastro-esophageal reflux symptoms in patients with antral gastritis: a triple blinded randomized controlled trial
Objectives: To investigate the effect of helicobacter pylori eradication regimen versus standard treatment on gastro-esophageal reflux symptoms in patients with antral gastritis Design: a triple blinded randomized controlled trial Setting and conduct: We will recruit 162 patients with heartburn and other symptoms of gastro-esophageal reflux disease who refer to Gastroenterology clinic. Participants including major eligibility criteria: The patient's with one of the following symptoms: gastro-esophageal reflux, dysphagia; heartburn; nausea; chest pain; and nuisance conditions that lead to awakening the patient will be included if they have endoscopic detection of gastritis and H. pylori infection in biopsy of gastric mucosa. Intervention: The control group will received standard treatment for reflux including Omeprazole 20 mg BID for two weeks. The intervention group will receive eradication treatment including Omeprazole 20 mg BID, Clarithromycin 500 mg BID, and Amoxicillin 1000 mg BID for two weeks. Main outcome measures (variables): The frequency and severity of reflux will be assessed four weeks after intervention via history taking of heartburn, regurgitation, nausea, dysphagia, chest pain, and nocturnal
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202229014N2
Registration date:2012-05-28, 1391/03/08
Registration timing:na
Last update:
Update count:0
Registration date
2012-05-28, 1391/03/08
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Not enough for processing
Funding source
Vic-chancellor of Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2012-05-21, 1391/03/01
Expected recruitment end date
empty
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of helicobacter pylori eradication regimen versus standard treatment on gastro-esophageal reflux symptoms in patients with antral gastritis: a triple blinded randomized controlled trial
Public title
Effect of helicobacter pylori eradication regimen versus standard treatment on gastro-esophageal reflux symptoms in patients with antral gastritis
Purpose
Treatment
Inclusion/Exclusion criteria
The patient's with one of the following symptoms: gastro-esophageal reflux, dysphagia; heartburn; nausea; chest pain; and nuisance conditions that lead to awakening the patient will be included if they have endoscopic detection of gastritis and H. pylori infection in biopsy of gastric mucosa.
The patents with following characteristics will be excluded from the study: simultaneous gastritis of fundus and antrum (pangastritis); gastric ulcer; duodenal ulcer; surgical history of esophagus, stomach, or duodenum; and history of using NSAIDs.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
162
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Local Human Subject Review board
Street address
Hamadan University of Medical Sciences, Shaheed Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2012-05-16, 1391/02/27
Ethics committee reference number
D/P/16/35/9/633
Health conditions studied
1
Description of health condition studied
Gastroesophageal reflux
ICD-10 code
K21.9
ICD-10 code description
Gastro-oesophageal reflux disease without oesophagitis
Primary outcomes
1
Description
Frequency and severity of reflux
Timepoint
After four weeks
Method of measurement
History taking of heartburn, regurgitation, nausea, dysphagia, chest pain, and nocturnal
Secondary outcomes
1
Description
Abdominal pain and diarrhea
Timepoint
Two weeks later
Method of measurement
History taking
Intervention groups
1
Description
Intervention group will receive eradication treatment including Omeprazole 20 mg BID, Clarithromycin 500 mg BID, and Amoxicillin 1000 mg BID for two weeks
Category
Treatment - Drugs
2
Description
Control group will receive standard treatment for reflux including Omeprazole 20 mg BID for two weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastroenterology subspecialty clinic of Shaheed Beheshti Hospital and private clinic
Full name of responsible person
Dr Ali Reza khalilian
Street address
Gastroenterology subspecialty clinic, Shaheed Beheshti Hospital, Eram Boulevard
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vic-chancellor of Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Ahmad Tavilani
Street address
Vic-chancellor of Research and Technology, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan
Grant name
از محل يك درصد بودجه طرحهاي تحقيقاتي دانشگاه
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vic-chancellor of Research and Technology, Hamadan 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
Research Center for Health Sciences and Department of Epidemiology & Biostatistics
Full name of responsible person
Dr Jalal Poorolajal
Position
MD, PhD, Assistant Professor of Epidemiology
Other areas of specialty/work
Street address
Research Center for Health Sciences and Department of Epidemiology & Biostatistics, School of Public Health, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan
Postal code
6517838695
Phone
+98 81 1838 0090
Fax
+98 81 1838 0509
Email
poorolajal@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Internal Medicine, School of Medicine
Full name of responsible person
Dr Ali Reza Khalilian
Position
Assistant Professor of Gastroenterology
Other areas of specialty/work
Street address
Department of Internal Medicine, School of Medicine, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan
Postal code
6517838695
Phone
Fax
Email
khalilian@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)