Tetracycline Versus Doxycycline for HP Rescue Therapy

Sponsor
Shanghai Zhongshan Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05018923
Collaborator
(none)
242
1
2
16.2
14.9

Study Details

Study Description

Brief Summary

This randomized controlled clinical trial will evaluate the efficacy and safety of proton pump inhibitor, bismuth, metronidazole, and either tetracycline or doxycycline for Helicobacter pylori rescue treatment. The completion of this trial will expand new therapy for the treatment of Helicobacter pylori.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
242 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Bismuth Quadruple Therapy With Tetracycline Versus Doxycycline as Rescue Therapy for Helicobacter Pylori Infection: a Randomized Controlled Trial
Actual Study Start Date :
Aug 24, 2021
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: RBMD group

Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and doxycycline 0.1 g bid for 14 days

Drug: Rabeprazole
20mg bid

Drug: Bismuth potassium citrate
0.6g bid

Drug: Metronidazole
0.4g qid

Drug: Doxycycline
0.1g bid

Active Comparator: RAMT group

Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and tetracycline 0.5 g qid for 14 days

Drug: Rabeprazole
20mg bid

Drug: Bismuth potassium citrate
0.6g bid

Drug: Metronidazole
0.4g qid

Drug: Tetracycline
0.5g qid

Outcome Measures

Primary Outcome Measures

  1. Eradication rate of Helicobacter pylori [At least 4 weeks after completion of therapy]

    Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value).

Secondary Outcome Measures

  1. Eradication rate of Helicobacter pylori resistant strains [At least 4 weeks after completion of therapy]

    Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value). The antibiotic resistant strains were assessed using the E test method.

  2. Eradication rate of Helicobacter pylori susceptible strains [At least 4 weeks after completion of therapy]

    Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value). The antibiotic susceptible strains were assessed using the E test method.

Other Outcome Measures

  1. Adherence rate [2 weeks during therapy]

    Adherence was defined as poor when subjects took less than 80% of the total medication.

  2. Frequency of adverse events [2 weeks during therapy]

    Any possible adverse events during the 14-day treatment period were recorded.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (ICF).

  • 18-75 years old on the day of signing the ICF.

  • Helicobacter pylori infection confirmed by 13C-urea breath test or rapid urease test.

  • Have failed eradication treatment before.

Exclusion Criteria:
  • Have not received Hp eradication treatment.

  • Patients with severe heart, lung, kidney, liver, blood, nerve, endocrine, and psychiatric diseases.

  • Subjects or guardians refused to participate in the trial.

  • Alcohol and/or drugs Abuse (addiction or dependence) or poor compliance with doctor's judgment.

  • Have taken antibiotics, bismuth, PPI or Chinese traditional medicine 4 weeks before treatment.

  • Pregnant or lactating women.

  • Active peptic ulcer.

  • allergic to drugs used in the trial.

  • any other circumstances that are not suitable for recruitment.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhongshan Hospital, Fudan University Shanghai Shanghai China 200032

Sponsors and Collaborators

  • Shanghai Zhongshan Hospital

Investigators

  • Principal Investigator: Taotao Liu, MD, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier:
NCT05018923
Other Study ID Numbers:
  • B2021-3763
First Posted:
Aug 24, 2021
Last Update Posted:
Aug 26, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 26, 2021