Doxycycline for Helicobacter Pylori Rescue Treatment

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05874570
• Other study ID #: rjhy20230002
• Status: Recruiting
• Phase: Phase 4
• Start date: June 20, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 368
• Est. completion date: December 31, 2024
• Est. primary completion date: December 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Helicobacter Pylori Infection

Intervention

Drug:
• Esomeprazole
Proton pump inhibitor
• Bismuth Potassium Citrate
Gastric mucosal protective drug with anti-H. pylori effect
• Tetracycline
Antibiotics for H. pylori eradication
• Doxycycline
Antibiotics for H. pylori eradication
• Metronidazole
Antibiotics for H. pylori eradication

Locations

Country	Name	City	State
China	Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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