Helicobacter Pylori and Lacidophilin Tablets in Combination With Vonorazan Dual Therapy

NCT05749081 | Active Not Recruiting Phase 4

• 1 other identifier: Hp therapy of FirstNanchangU
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Helicobacter pylori; vonoprazan; Lacidophilin Tablets; amoxicillin; eradication

Outcome Measures

Primary Outcomes (1)

• Efficacy of Treatment

  The confirmation of H. pylori status was evaluated by urea breath test

  4-8 weeks after treatment

Secondary Outcomes (4)

• Incidence of Treatment-Emergent Adverse Events

  1 day after eradication

• Compliance of Participants

  1 day after eradication

• Resistance of Antibiotics

  before the eradication

• Alteration of Gut Microbiota

  before eradication，1 day after eradication and confirmation（4-8 weeks after treatment）

Study Arms (2)

Lacidophilin tablets group

EXPERIMENTAL

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

Drug: Lacidophilin tablets in combination with vonorazan dual therapy

Placebo group

PLACEBO COMPARATOR

2400mg placebo 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

Interventions

Lacidophilin tablets in combination with vonorazan dual therapy DRUG

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

Lacidophilin tablets group

Placebo in combination with vonorazan dual therapy DRUG

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

Placebo group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consecutive H. pylori-infected subjects ages from 18 to 70 without eradication history

You may not qualify if:

• allergy to amoxicillin,vonoprazan or lacidophilin tablets;
• acute upper gastrointestinal bleeding, gastric cancer or other tumors, Zollinger-Ellison syndrome, history of gastric surgery;
• gastroscopy report showing or past medical history of significant esophagogastric disease, including gastric cancer, peptic ulcer, esophagitis, esophageal erosion.
• serious illness including neurological, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, endocrinological or hematological disorders;
• pregnancy or breast feeding;
• proton pump inhibitors, antibiotics and probiotics use within one month;
• not willing to participate in the study.

Sponsors & Collaborators

• The First Affiliated Hospital of Nanchang University: lead

Study Sites (1)

The first affiliated hospital, Jiangxi Medical College, NanChang University

Nanchang, Jiangxi, China

Location

Study Officials

• Cong He, phD

  The First Affiliated Hospital of Nanchang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 18, 2023
• First Posted: March 1, 2023
• Study Start: May 13, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)