High Dose of Amoxicillin and Metronidazole Plus Bismuth For Helicobacter Pylori Treatment

NCT03557437 | Completed Phase 4 DMC

• 1 other identifier: rjkls2018037
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

Amoxicillin and metronidazole （400mg Q.D.S） based quadruple therapy had achieved a high cure rate in the rescue treatment of helicobacter pylori infection. This study aims to evaluate the efficacy and safety of the amoxicillin and metronidazole (400mg thrice a day) based triple therapy and the addition of bismuth in the naive patients with helicobacter pylori infection.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori Therapy

Outcome Measures

Primary Outcomes (1)

• Helicobacter pylori eradication rate

  Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (\<4‰) (4‰ as the cutoff value).

  Six weeks after completion of therapy

Secondary Outcomes (2)

• Rate of adverse effects

  Within 7 days after completion of therapy

• Compliance rate

  Within 7 days after completion of therapy

Study Arms (2)

Triple Therapy

ACTIVE COMPARATOR

Esomeprazole 20mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days

Drug: Esomeprazole; Drug: Amoxicillin, Metronidazole

Bismuth Plus Triple Therapy

EXPERIMENTAL

Esomeprazole 20mg bid, Bismuth Potassium Citrate 600mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days

Drug: Esomeprazole; Drug: Amoxicillin, Metronidazole; Drug: Bismuth Potassium Citrate

Interventions

Esomeprazole DRUG

Proton pump inhibitor

Bismuth Plus Triple Therapy; Triple Therapy

Amoxicillin, Metronidazole DRUG

Antibiotics for H. pylori eradication

Bismuth Plus Triple Therapy; Triple Therapy

Bismuth Potassium Citrate DRUG

Gastric mucosal protective drug with anti-H. pylori effect

Bismuth Plus Triple Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with non-ulcer functional dyspepsia or peptic ulcer disease
• Ability and willingness to participate in the study and to sign and give informed consent
• Confirmed H. pylori infection and with no previous treatment experience

You may not qualify if:

• Less than 18 years old
• With previous gastric surgery
• Major systemic diseases
• Pregnancy or lactation

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

Location

Related Publications (1)

• Luo L, Ji Y, Yu L, Huang Y, Liang X, Graham DY, Lu H. 14-Day High-Dose Amoxicillin- and Metronidazole-Containing Triple Therapy With or Without Bismuth as First-Line Helicobacter pylori Treatment. Dig Dis Sci. 2020 Dec;65(12):3639-3646. doi: 10.1007/s10620-020-06115-7. Epub 2020 Feb 4.

  PMID: 32020360 DERIVED

MeSH Terms

Interventions

Esomeprazole; Amoxicillin; Metronidazole

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles

Study Officials

• Hong Lu, M.D

  Renji Hospital, School of Medicine, Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: June 15, 2018
• Study Start: May 25, 2018
• Primary Completion: June 10, 2019
• Study Completion: June 10, 2019
• Last Updated: June 18, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)