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Determining and comparing the effect of probiotic(Sabular) and Rosuvastatin on the success of four-drug treatment to eradicate Helicobacter pylori

Phase 3
Conditions
Helicobacter pylori.
Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere
B96.81
Registration Number
IRCT20230827059280N1
Lead Sponsor
Esfahan University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
255
Inclusion Criteria

Having a positive stool antigen test for H. pylori
Having at least one indication for the treatment of H. Pylori including: 1. Patients with dyspepsia and a positive stool Ag test for H. Pylori, (according to the prevalence >20% of Helicobacter pylori infection in the Iranian population) 2. Patients with resistant dyspepsia and Positive gastric biopsy for Helicobacter in endoscopy 3. Patients with dyspepsia with unknown cause and age less than 60 years who have a positive stool Ag test. 4. Patients with a positive stool Ag test who need long-term treatment with NSAID 5. Patients with early stages of gastric cancer who have undergone resection surgery. 6. Patients with a high risk of gastric cancer (first degree family of a person with gastric cancer, extensive gastritis or severe atrophy of gastric mucosa, history of gastric neoplasm) people treated with gastric acid secretion inhibitors for more than 1 year, the presence of environmental risk factors for stomach cancer or the patient's great fear of stomach cancer)

Exclusion Criteria

Pregnancy and breastfeeding at the time of study
Immune deficiency
Recent history of macrolide use
Allergy to penicillin
Not currently taking statins and probiotics
The presence of contraindications for rosuvastatin use (history of hypersensitivity reaction to rosuvastatin or substances added to the composition of rosuvastatin tablets, increased liver enzymes AST, ALT without a specific cause, acute liver failure, uncompensated liver cirrhosis, pregnancy or breastfeeding)

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Helicobacter pylori stool specific antigen test result. Timepoint: Conducting Helicobacter pylori fecal specific antigen test before the start of the study to determine the criteria for the patient to enter the study and 4 weeks after the completion of the 2-week treatment. Method of measurement: Helicobacter pylori stool specific antigen test.
Secondary Outcome Measures
NameTimeMethod
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