The study groups are probiotic and control ( 60 patients in each group) with confirmed H. Pylori infection by either fecal H.Pylori antigen or Urea Breath Test . Both groups will receive a 10-day standard H.Pylori eradication regimen ( Amoxicillin and Clarithromycin and Omeprazol) ; but the probiotic preparation would be introduced for probiotic group.
4 weeks after finishing of treatment, the eradication will be confirmed by either fecal H.Pylori antigen or Urea Breath Test. The rate of eradication and patient's compliance and side effects will be compared between two study groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015071523219N1
Registration date:2015-10-21, 1394/07/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-10-21, 1394/07/29
Registrant information
Name
Hadi Karimzadeh
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5770
Email address
karimzadeh@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2015-10-22, 1394/07/30
Expected recruitment end date
2016-08-20, 1395/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapeutic effectiveness of Probiotic on eradication of Helicobacter Pylori infection in Adults
Public title
Therapeutic effectiveness of Probiotic in GI Infection
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:
Age >18 Years; Dyspepsia; confirmed H.Pylori
Exclusion criteria :
acute and chronic GI disease; Renal failure; Neurological disease; use of Antibiotic or probiotic within previous 30 days
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Zahedan University of Medical Sciences
Street address
University Campus, Hesabi Square,
City
Zahedan
Postal code
Approval date
2015-06-28, 1394/04/07
Ethics committee reference number
IR.Zaums.Re.1394.145
Health conditions studied
1
Description of health condition studied
Helicobacter pylori Infection
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
H.pylori Infection
Timepoint
Before and 4 weeks after end of treatment
Method of measurement
Fecal H.pylori or Urea Breathing Test
Secondary outcomes
1
Description
Allergia; Diarrea; Nausea; Vometing; Bloating
Timepoint
Before and 4 weeks after end of treatment
Method of measurement
Hystory and Physical exam
Intervention groups
1
Description
B group : cap placebo/ 1 cap / q 12 h and standard regimen for H. pylori eradication
Category
Placebo
2
Description
A group: cap Familact / 1 cap/ q 12 h and standard regimen for H. pylori eradication
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali-Ebne-Abitaleb Hospital
Full name of responsible person
Street address
Department of Internal Medicine, Ali-Ebne-Abitaleb Hospital
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hadi Karimzadeh, M.D
Street address
Department of Internal Medicine, Ali-Ebne-Abitaleb Hospital
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Alireza Bakhshipour, M.D
Position
Gastroenterologist
Other areas of specialty/work
Street address
Department of Internal Medicine, Ali-Ebne-Abitaleb Hospital
City
Zahedan
Postal code
Phone
+98 54 3329 5577
Fax
Email
Arbakhshipour@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
َAlireza Bakhshipour, M.D
Position
Gastroenterologist
Other areas of specialty/work
Street address
Department of Internal Medicine, Ali-Ebne-Abitaleb Hospital
City
Zahedan
Postal code
Phone
00985433295577_78
Fax
Email
Arbakhshipour@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hadi Karimzadeh, M.D
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)