Study of the effect of adding probiotic and simvastatin on eradication rate of Helicobacter pylori
Design
Individuals are divided into four groups based on random permutations, Patients and physicians do not know how to get people in groups.
Settings and conduct
In this study, people referred to the gastroenterology clinic of Imam Khomeini Hospital in Ahwaz who were confirmed by endoscopy and confirmed by Helicobacter pylori infection biopsy and not treated with Helicobacter pylori eradication were randomly divided into 4 groups. . Patients and physicians do not know how to get people in groups.
Participants/Inclusion and exclusion criteria
Criteria for entering the study:
1. Be over 18 years old.
2. Satisfy.
3. Has been positive for H. pylori and has not received treatment until now.
Exit criteria:
1. Lack of satisfaction
2. Have a history of recent antibiotic intake
3. Contra indications of probiotic or simvastatin intake or drug related drug use during drug use.
4. Alcohol consumption
5. Smoking
Intervention groups
1. The first group is a single dose of pentaprazole (40 mg bid), amoxicillin (1000 mg bid), clarithromycin (500 mg bid), bismuth (120 mg bid), and placebo once daily.
2. The second group received buprenorphine pentaprazole (40 mg bid), amoxicillin (1000 mg bid), clarithromycin (500 mg bid) and bismuth (120 mg bid) + probiotic (daily east 250 mg daily).
3. The third group received pantoprazole (40 mg bid), amoxicillin (1000 mg bid) and clarithromycin (500 mg bid) and bismuth (120 mg bid) + simvastatin (10 mg daily).
4. The fourth group is prescribed pantoprazole (40 mg bid), amoxicillin (1000 mg bid) and clarithromycin (500 mg bid) and bismuth (120 mg bid) + simvastatin (20 mg daily).
Main outcome variables
Comparison of Helicobacter pylori eradication in the studied groups: Drug and Placebo - Drug + Probiotics - Drug + Simvastatin 10mg - Drug + Simvastatin 20mg
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180130038566N1
Registration date:2018-05-13, 1397/02/23
Registration timing:retrospective
Last update:2018-05-13, 1397/02/23
Update count:0
Registration date
2018-05-13, 1397/02/23
Registrant information
Name
maryam biuseh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3292 1839
Email address
maryam.biuseh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
2017-03-21, 1396/01/01
Actual recruitment end date
2018-01-20, 1396/10/30
Trial completion date
empty
Scientific title
Study of probiotic and simvastatin additive effect on Helicobacter eradication rate
Public title
Eradication of Helicobacter
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Is over 18 years old.
Is satisfied.
In terms of Helicobacter pylori, it has not been treated until now.
Exclusion criteria:
Dissatisfaction.
Have a history of recent antibiotic intake.
Contra has indications of receiving probiotic or simvastatin, or when it comes to drug use during drug use.
alcohol consumption.
smoking.
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
160
Actual sample size reached:
160
Randomization (investigator's opinion)
Randomized
Randomization description
According to the 8th permutation block method, individuals are randomly divided into 2 groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the group receiving the placebo capsule, 1 placebo tablet was given as simvastatin tablets and placebo.
One group who received simvastatin tablets and placebo was given 1 placebo capsule similar to the probiotic capsule.
The number and type of medication used in all groups was the same.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University
Street address
Ahvaz - Golestan - Jundishapur University of Ahvaz
City
ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-01-20, 1396/10/30
Ethics committee reference number
IR.AJUMS.REC.1396.892
Health conditions studied
1
Description of health condition studied
Helicobacter pylori
ICD-10 code
B96.81
ICD-10 code description
Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere
Primary outcomes
1
Description
Eradication rate of Helicobacter pylori
Timepoint
Patients are treated for two weeks, after which treatment is discontinued and four weeks after completion of the treatment, a fecal antigen test for eradication of Helicobacter pylori infection is examined.
Method of measurement
Measurement of Helicobacter pylori in Ahvaz Imam Khomeini Hospital Laboratory.