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Helicobacter Pylori and Lacidophilin Tablets in Combination With Vonorazan Dual Therapy

NCT05749081 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 324

Last updated 2024-06-18

No results posted yet for this study

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.

Conditions

  • Helicobacter Pylori Infection

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

Sponsors & Collaborators

  • The First Affiliated Hospital of Nanchang University

    lead OTHER

Principal Investigators

  • Cong He, phD · The First Affiliated Hospital of Nanchang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-13
Primary Completion
2024-07-31
Completion
2024-07-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05749081 on ClinicalTrials.gov