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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

Determining and comparing the effect of probiotic(Sabular) and Rosuvastatin on the success of four-drug treatment to eradicate Helicobacter pylori in patients referred to the Gastrointestinal Clinic of Al-Zahra Hospital from December 2023 to March 2025

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230827059280N1
Enrollment
255
Registered
2023-10-09
Start date
2023-12-22
Completion date
Unknown
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter pylori. Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere

Interventions

Intervention 1: Control group: This group of patients receives the standard 4-drug regimen for Helicobacter pylori including Esomeprazole plus Clarithromycin plus Amoxicillin plus Bismuth for 2 weeks.

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Jafari

Esfahan University of Medical Sciences

m.jafari@med.mui.ac.ir+98 31 3822 0000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026