Doxycycline for Helicobacter Pylori Rescue Treatment

Doxycycline-containing Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment: a Randomized Controlled Trial

Current guidelines have recommended classical bismuth-containing quadruple therapy including proton-pump inhibitor, bismuth, tetracycline, metronidazole as the empirical rescue therapy. However, tetracycline is clinically unavailable in China and the high frequency of adverse events of bismuth quadruple therapy often result in poor compliance, which limited the applicability of this recommendation. This study aimed to compare the efficacy and tolerability of a 14-day bismuth-containing quadruple rescue therapy in which tetracycline was replaced by doxycycline.

Study Overview

• Status: Recruiting
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Esomeprazole; Drug: Bismuth Potassium Citrate; Drug: Tetracycline; Drug: Metronidazole; Drug: Doxycycline

• Study Type: Interventional
• Enrollment (Estimated): 368
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Recruiting
      • Renji Hospital, School of Medicine, Shanghai Jiao Tong University
      • Contact: Yu Huang, M.M.; Phone Number: 86+18621791879; Email: 15626211482@163.com
      • Contact: Hong Lu, M.D.,Ph.D
      • Contact: Jinnan Chen, M.M.
      • Contact: Yixian Guo, M.M.
      • Contact: Xiao Liang, M.D.,Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Ability and willingness to participate in the study and to sign and give informed consent
• Confirmed H. pylori infection and with previous treatment failure

Exclusion Criteria:

• subjects naive to H. pylori treatment,
• under 18 or over 80 years old
• history of gastrectomy
• pregnant or lactating women
• severe systemic diseases or malignancy
• administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tetracycline Bismuth Quadruple Therapy; Esomeprazole 20mg bid, Bismuth Potassium Citrate 110mg qid, Tetracycline 500mg qid, Metronidazole 400mg qid	Drug: Esomeprazole; Proton pump inhibitor; Drug: Bismuth Potassium Citrate; Gastric mucosal protective drug with anti-H. pylori effect; Drug: Tetracycline; Antibiotics for H. pylori eradication; Drug: Metronidazole; Antibiotics for H. pylori eradication
Experimental: Doxycycline Bismuth Quadruple Therapy; Esomeprazole 20mg bid, Bismuth Potassium Citrate 110mg qid, Doxycycline 100mg bid, Metronidazole 400mg qid	Drug: Esomeprazole; Proton pump inhibitor; Drug: Bismuth Potassium Citrate; Gastric mucosal protective drug with anti-H. pylori effect; Drug: Metronidazole; Antibiotics for H. pylori eradication; Drug: Doxycycline; Antibiotics for H. pylori eradication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of adverse effects	The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or "severe" (causing considerable interference with daily activities)	Within 7 days after completion of therapy
Compliance rate	Compliance was defined as poor when they had taken less than 80% of the total medication	Within 7 days after completion of therapy

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2023
• Primary Completion (Estimated): October 10, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: May 16, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 26, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Helicobacter pylori; doxycycline; rescue therapy; tetracycline
• Additional Relevant MeSH Terms: Anti-Bacterial Agents; Anti-Infective Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Enzyme Inhibitors; Antimalarials; Antiprotozoal Agents; Antiparasitic Agents; Expectorants; Respiratory System Agents; Antacids; Protein Synthesis Inhibitors; Diuretics; Natriuretic Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Metronidazole; Tetracycline; Potassium Citrate; Bismuth; Doxycycline; Esomeprazole
• Other Study ID Numbers: rjhy20230002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No