Evaluation of the frequency of Helicobacter negative and positive subjects after adjuvant treatment with statin
we therefore decided to find out by designing this study whether it is possible to Should we use two drugs as adjunctive therapy to eradicate HP
Design
Patients are randomly divided into three groups, two intervention groups and one control group. Randomization will be done by block method with a block size of six. Double-blind randomization will be done by sealed envelopes.
Settings and conduct
In this clinical trial study, patients referred to the internal medicine and gastroenterology clinic of Qaim Hospital who were subjected to the stool HP antigen test due to dyspepsia to check for HP and reported a positive STEF test were included in the study if they were eligible and gave informed consent
Participants/Inclusion and exclusion criteria
Informed written consent
Helicobacter pylori positive patients with definitive diagnosis by stool HP antigen test referring to Ghaem Hospital
Age category 18 years and above
Intervention groups
Patients are randomly divided into three groups, two intervention groups and one control group
The control group only received first-line treatment for HP eradication, which included amoxicillin at a dose of 1 g every 12 hours for 14 days, clarithromycin 500 mg every 12 hours for 14 days, and pantoprazole 40 mg daily for one month, and placebo They will be placed for 14 days. The first intervention group will receive rosavastatin 5 mg twice daily for 14 days in addition to the three-drug eradication therapy described above
Main outcome variables
The effectiveness of drugs in the treatment of Helicobacter pylori infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231017059756N1
Registration date:2023-11-06, 1402/08/15
Registration timing:registered_while_recruiting
Last update:2023-11-06, 1402/08/15
Update count:0
Registration date
2023-11-06, 1402/08/15
Registrant information
Name
Javad Aishy
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3822 6605
Email address
aishy.m5@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2025-10-23, 1404/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the therapeutic effect of statin relative to the N-acetyl cysteine in the treatment of Helicobacter pylori patients
Public title
Investigating the therapeutic effect of statin relative to the N-acetyl cysteine in the treatment of Helicobacter pylori patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed written consent
Helicobacter pylori positive patients with definitive diagnosis by stool HP antigen test referring to Ghaem Hospital
Age category 18 years and above
Exclusion criteria:
Canceling the continuation of the plan
pregnancy
breastfeeding
Weight loss of more than 5% over the past six months
Dysphagia and positive personal or family history of gastrointestinal malignancy
Receiving statin and NAC during the last 6 months
Having a history of gastric surgery
Receiving PPI and antibiotics in the past month
The presence of known drug sensitivity to any of the drugs used
Known liver problems
The presence of obvious gastrointestinal bleeding
Occurrence of possible drug side effects due to drug intervention and possible myopathy due to statin use
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Using the site www.randomization.com, in the randomization part of the site, after selecting create a list, specify the number of groups, block sizes and the length of the list, and based on that, randomization of the list is provided
Blinding (investigator's opinion)
Double blinded
Blinding description
Sealed envelopes of medicine
Placebo
Used
Assignment
Crossover
Other design features
no
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences
City
mashhad
Province
Razavi Khorasan
Postal code
9177137559
Approval date
2023-10-14, 1402/07/22
Ethics committee reference number
4020375
Health conditions studied
1
Description of health condition studied
Helicobacter pylori patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Helicobacter pylori infection recovery rate
Timepoint
Before starting treatment and one month after starting treatment
Method of measurement
Based on Helicobacter pylori antigen test in stool exam
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: receiving a 14-day regimen of Helicobacter plus statin
Category
Other
2
Description
Intervention group: receiving a 14-day regimen of Helicobacter plus n a cystein
Category
Other
3
Description
Control group: Receiving a 14-day Helicobacter regimen with placebo
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Internal medicine and gastroenterology clinic of ghaem Hospital, Mashhad