The Efficiency of Probiotic on Helicobacter Pylori Eradication, a Retrospective Parallel Group Double-Blind, Placebo-Controlled Randomized Clinical Trial
Evaluation of effect of probiotic on H. pylori eradication
Design
A parallel double-blind placebo-controlled trial, using computer package which generated random numbers, simple random allocation rule, with 100 participants.
Settings and conduct
Double-blind placebo-controlled trial, using labratory tests for evaluation of eradication,using symptoms questionnare.
Participants/Inclusion and exclusion criteria
Adult patients who their infection confirmed through histology, serum anti-H. pylori IgG, or stool antigen tests.
The exclusion criteria were; taking antibiotics, bismuth component, proton pump inhibitor (PPI), and H2Blocker in the recent 2-3 months, pregnant women, patients with previous history of GI surgery, having concurrent severe disease during the time of experiment
Intervention groups
Treatment group should take probiotic, despite control group with taking placebo for two weeks.Both of them take this regimen; Omeprazole 20mg +Amoxicillin 1 gr + clarithromycin 500 mg twice daily, and with 6 weeks followed up study.
Main outcome variables
Finding new strategy or supplementation for eradication of this infection due to prevalence of drug therapy resistance and related side effects.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181015041349N1
Registration date:2019-02-09, 1397/11/20
Registration timing:retrospective
Last update:2019-02-09, 1397/11/20
Update count:0
Registration date
2019-02-09, 1397/11/20
Registrant information
Name
Seyed Jalil Masoumi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3233 2771
Email address
ebrahimiv@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-05-21, 1394/02/31
Expected recruitment end date
2015-09-20, 1394/06/29
Actual recruitment start date
2015-06-21, 1394/03/31
Actual recruitment end date
2015-11-05, 1394/08/14
Trial completion date
2015-11-05, 1394/08/14
Scientific title
The Efficiency of Probiotic on Helicobacter Pylori Eradication, a Retrospective Parallel Group Double-Blind, Placebo-Controlled Randomized Clinical Trial
Public title
The Efficiency of Probiotic on Helicobacter Pylori Eradication
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with aged 18-63 years
participants who their contamination were confirmed through histology, serum anti-H. pylori IgG, or stool antigen tests.
Exclusion criteria:
The exclusion criteria were taking antibiotics, bismuth component, proton pump inhibitor (PPI), and H2Blocker in the recent 2-3 months.
Pregnant women as well as patients with previous history of GI surgery or having concurrent severe disease during the time of experiment also been excluded.
Age
From 18 years old to 63 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was conducted using computer package which generated random numbers and group allocation was as well done by simple random allocation rule. Couples were randomly allocated into either probiotic (50 subjects, group A) or placebo (50 subjects, group B).
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
Ethics committee of Shiraz university of medical science
Street address
Zand avenue
City
Shiraz
Province
Fars
Postal code
7376116678
Approval date
2015-04-18, 1394/01/29
Ethics committee reference number
3901
Health conditions studied
1
Description of health condition studied
Effect of Probiotic on Eradication of H.pylori Infection
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Eradication of H.pylori Infection
Timepoint
before intervention and 8 weeks later (after follow-up)
Method of measurement
histology, serum anti-H. pylori IgG, or stool antigen tests.