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ACTIVE NOT RECRUITING
NCT05749081
PHASE4

Helicobacter Pylori and Lacidophilin Tablets in Combination With Vonorazan Dual Therapy

Sponsor: The First Affiliated Hospital of Nanchang University

View on ClinicalTrials.gov

Summary

Our previous study included 119 Helicobacter pylori(H. pylori)-infected Chinese patients without previous eradication history who were randomized to low-or high-dose amoxicillin-vonoprazan regimens consisting of amoxicillin 1 gram either b.i.d. or t.i.d plus vonoprazan 20 mg b.i.d for 7 or 10 days. Neither 7-or 10-day VA dual therapy with either b.i.d. or t.i.d. amoxicillin achieved satisfied efficacy (i.e., \<90%) when given as first-line treatment for H. pylori infection. Lacidophilin tablets have been reported to increase the eradication rate of H. pylori while reducing the incidence of adverse effects.This study evaluated the efficacy and safety of lacidophilin tablets in combination with amoxicillin-vonoprazan dual therapy for 10 days as first-line treatment for H. pylori in China.

Official title: Lacidophilin Tablets in Combination With Vonorazan and Amoxicillin Dual Therapy for Eradicating Helicobacter Pylori Infection: a Prospective, Multi-centers, Superiority, Double-blind, Randomized Clinical Study

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

324

Start Date

2023-05-13

Completion Date

2024-07

Last Updated

2024-06-18

Healthy Volunteers

No

Interventions

DRUG

Lacidophilin tablets in combination with vonorazan dual therapy

2400mg lacidophilin tablets three times daily,1000mg amoxicillin capsules three times daily and 20mg vonoprazan Fumarate Tablets twice daily for 10 days

DRUG

Placebo in combination with vonorazan dual therapy

2400mg placebo three times daily,1000mg amoxicillin capsules three times daily and 20mg vonoprazan Fumarate Tablets twice daily for 10 days

Locations (1)

The first affiliated hospital, Jiangxi Medical College, NanChang University

Nanchang, Jiangxi, China