Rescue Therapy for Helicobacter Pylori Eradication

Sponsor

Shanghai Jiao Tong University School of Medicine (Other)

Overall Status

Recruiting

CT.gov ID

NCT04531059

Collaborator

(none)

368

Enrollment

Location

Arms

21.5

Anticipated Duration (Months)

17.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Tetracycline and metronidazole 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 minocycline and metronidazole based bismuth quadruple therapy in the rescue treatment of helicobacter pylori infection.

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori Infection	Drug: Esomeprazole Drug: Bismuth Potassium Citrate Drug: Tetracycline,Metronidazole Drug: Minocycline,Metronidazole	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

368 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Rescue Therapy for Helicobacter Pylori Eradication: A Randomized Non-Inferiority Trial of Minocycline or Tetracycline in Bismuth Quadruple Therapy

Actual Study Start Date :

Oct 15, 2020

Anticipated Primary Completion Date :

Jul 30, 2022

Anticipated Study Completion Date :

Jul 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Tetracycline Bismuth Quadruple Therapy Esomeprazole 20mg bid Bismuth Potassium Citrate 300mg bid 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,Metronidazole Antibiotics for H. pylori eradication
Experimental: Minocycline Bismuth Quadruple Therapy Esomeprazole 20mg bid Bismuth Potassium Citrate 300mg bid Minocycline 100mg bid Metronidazole 400mg qid	Drug: Esomeprazole Proton pump inhibitor Drug: Bismuth Potassium Citrate Gastric mucosal protective drug with anti-H. pylori effect Drug: Minocycline,Metronidazole Antibiotics for H. pylori eradication

Arm

Intervention/Treatment

Active Comparator: Tetracycline Bismuth Quadruple Therapy

Esomeprazole 20mg bid Bismuth Potassium Citrate 300mg bid 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,Metronidazole

Antibiotics for H. pylori eradication

Experimental: Minocycline Bismuth Quadruple Therapy

Esomeprazole 20mg bid Bismuth Potassium Citrate 300mg bid Minocycline 100mg bid Metronidazole 400mg qid

Drug: Esomeprazole

Proton pump inhibitor

Drug: Bismuth Potassium Citrate

Gastric mucosal protective drug with anti-H. pylori effect

Drug: Minocycline,Metronidazole

Antibiotics for H. pylori eradication

Outcome Measures

Primary Outcome Measures

Helicobacter pylori eradication rate [Six weeks after completion of therapy]
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).

Secondary Outcome Measures

Rate of adverse effects [Within 7 days after completion of therapy]
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)
Compliance rate [Within 7 days after completion of therapy]
Compliance was defined as poor when they had taken less than 80% of the total medication

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 experience

Exclusion Criteria:

Less than 18 years old
With previous gastric surgery
Major systemic diseases
Pregnancy or lactation
Allergy to any of the study drugs Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai	China	200127

Sponsors and Collaborators

Shanghai Jiao Tong University School of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hong Lu, MD, Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine, Shanghai Jiao Tong University School of Medicine

ClinicalTrials.gov Identifier:

NCT04531059

Other Study ID Numbers:

rjkls2019013

First Posted:

Aug 28, 2020

Last Update Posted:

Apr 5, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hong Lu, MD, Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine, Shanghai Jiao Tong University School of Medicine

Helicobacter pylori Therapy

Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 5, 2022