Doxycycline for Helicobacter Pylori Rescue Treatment

Sponsor

Shanghai Jiao Tong University School of Medicine (Other)

Overall Status

Recruiting

CT.gov ID

NCT05874570

Collaborator

(none)

368

Enrollment

Location

Arms

19.5

Anticipated Duration (Months)

18.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori Infection	Drug: Esomeprazole Drug: Bismuth Potassium Citrate Drug: Tetracycline Drug: Doxycycline Drug: 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:

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

Anticipated Study Start Date :

May 16, 2023

Anticipated Primary Completion Date :

Dec 10, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

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: Doxycycline Antibiotics for H. pylori eradication Drug: Metronidazole Antibiotics for H. pylori eradication

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: Doxycycline

Antibiotics for H. pylori eradication

Drug: 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 70 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 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

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:

NCT05874570

Other Study ID Numbers:

rjhy20230002

First Posted:

May 25, 2023

Last Update Posted:

May 25, 2023

Last Verified:

May 1, 2023

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

Additional relevant MeSH terms:

Study Results

No Results Posted as of May 25, 2023