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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20220201001

Enrollment

234

Registered

2022-02-01

Start date

2022-02-02

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Treatment in patients with Helicobacter pylori infection Standard triple regimens, Statin, Helicobacter pylori, H.pylori, Eradication

Interventions

Omeprazole 20mg 1 tab oral bid ac, Amoxicillin 500mg 2 tab oral bid pc, Clarithromycin 500mg 1 tab oral bid pc, Atorvastatin 40 mg 1 tab oral hs Duration 14 days,Omeprazole 20mg 1 tab oral bid ac, A

Active Comparator Drug,Placebo Comparator Drug

Statin group,Placebo group

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Eradication rate of H.pylori 6 week after intervention Percentage	—

Secondary

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

Countries

Thailand

Contacts

Public ContactChitchai Rattananukrom

Department of Medicine, Faculty of Medicinem Khon Kaen University

Chitra@kku.ac.th0813004969

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026