Efficacy of standard triple therapy with statin compared with standard triple therapy in Helicobacter pylori eradication: A randomized double- blind placebo-controlled trial

Phase 4

• Conditions: Treatment in patients with Helicobacter pylori infection; Standard triple regimens, Statin, Helicobacter pylori, H.pylori, Eradication

• Registration Number: TCTR20220201001
• Lead Sponsor: The Gastroenterological Association of Thailand (GAT)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-01
• Study Completion: 2022-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 234

Inclusion Criteria

1.H.pylori infection patients by use of Invasive test: EGD with CLO test/Biopsy or Non-invasive test: UBT, stool Antigen
2.Aged more than 18 years
3.Can read and write of Thai language.

Exclusion Criteria

1.Previous treatment with statin, 2.Presence of severe comorbidities, 3. Gastrointestinal malignancy or previous gastric surgery, 4.Prior H. pylori eradication therapy, 5.History of antibiotics, PPI, histamine H2 receptor blockers, nonsteroidal or anti-inflammatory drugs, bismuth salts within the last month, 6. Allergy of any of the antibiotics used, statin in the study,7. Active upper gastrointestinal bleeding, 8.Pregnant or breastfeeding women, 9. Ongoing use of drug that may interaction with atorvastatin such as cyclosporine, protease inhibitors, itraconazole, 10. Active hepatitis or rhabdomyolysis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Eradication rate of H.pylori 6 week after intervention Percentage

Secondary Outcome Measures

Name	Time	Method
Safety of statin use in helicobacter pylori treatment with standard triple therapy 2-4 week Quantitative and grading of severity