The aim of the present study is to determine the efficacy of 4 drug regimen with and without Prebiotic and probiotic for H Pylori eradication in patient with peptic ulcer. 4 drug regimens are including: Metronidazole, amoxicillin, omeprazole, Bismuth. Sample size is 60 patients including 30 case and 30 control.
Patients has been selected with endoscopically diagnosed duodenal ulcers associated with Helicobacter pylori infection and Rapid Urease test.Cases will take 4 drug regimens as well as Prebiotic and probiotic component in capsules with name of Protexin Protect twice daily for one month.
Study is done by Double blind randomized. H Pylori eradication will be done by Urease breath test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138711231680N1
Registration date:2010-02-06, 1388/11/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-02-06, 1388/11/17
Registrant information
Name
Ashraf Hosseini
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 1613 1362
Email address
ashosaini@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan University of Medical Sciencs
Expected recruitment start date
2009-06-22, 1388/04/01
Expected recruitment end date
2009-12-22, 1388/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of probiotic and prebiotic composition on standard regimens for H. pylori eradication
Public title
Study on H. pylori eradication
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Satisfaction to accompany, Confirmed duodenal ulcers by endoscopy, Positive RUT
Exclusion criteria included previous H. pylori eradication therapy or gastric surgery, allergy to drugs, pregnancy, anti fungal treatment and incomplete drug application
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Kurdestan University of Medical Sciences
Street address
Kurdestan University of Medical Science, Sanandaj.Kurdestan, Iran
City
Sanandaj
Postal code
13446- 66177
Approval date
2008-12-23, 1387/10/03
Ethics committee reference number
9045
Health conditions studied
1
Description of health condition studied
H pylori eradication in Duodenal ulcer
ICD-10 code
K26
ICD-10 code description
Duodenal ulcer
Primary outcomes
1
Description
Reducing signs
Timepoint
15 ِDays
Method of measurement
Medical examination
2
Description
Helicobacter eradication
Timepoint
1 month
Method of measurement
urea breath test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 4 drug standard regimens for Iran including:amoxicillin 1 gr twice daily, metronidazole 500 mg twice daily, Omeprazole 20 mg twice daily and bismuth citrate 400mg QID as well as probiotic and prebiotic component (Protexin Protect)
Category
Treatment - Drugs
2
Description
Control group: 4 drug standard regimens and placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kurdestan Digestive Research Center
Full name of responsible person
Dr Ashraf Hosseini
Street address
Tohid hospital
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Management, Kurdistan University of Medical Sciences
Full name of responsible person
Dr Haidari
Street address
Research Management, Kurdistan University of Medical Science, Pasdaran Ave
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Management, Kurdistan 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
Kurdestan University of Medical Sciences
Full name of responsible person
Dr Ashraf Hosseini
Position
PhD
Other areas of specialty/work
Street address
Kurdestan University of Medical Sciences
City
Sanandaj
Postal code
66177-13446
Phone
+98 87 1613 1362
Fax
+98 87 1666 4674
Email
ashosaini@muk.ac.ir & ashosaini@yahoo.co.in
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kurdestan digestive Research Center, Kurdestan University of Medical Sciences
Full name of responsible person
Dr Ashraf Hosseini
Position
PhD, Researcher
Other areas of specialty/work
Street address
Kurdestan University of Medical Sciences
City
Sanandaj
Postal code
66177-13446
Phone
+98 87 1613 1362
Fax
+98 87 1666 4674
Email
ashosaini@muk.ac.ir & ashosaini@yahoo.co.in
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Dr Ashraf Hosseini
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)