Susceptibility-guided sequential strategy versus empirical therapy for Helicobacter pylori infection: study protocol...

Area of Science:

• Gastroenterology
• Infectious Diseases
• Molecular Diagnostics

Background:

• Helicobacter pylori infections are increasingly resistant to antibiotics, necessitating new treatment strategies.
• Current meta-analyses on susceptibility-guided vs. empirical H. pylori therapy have limitations and contradictory results.
• Polymerase chain reaction (PCR)-based antibiotic susceptibility testing can detect H. pylori resistance mutations.

Purpose of the Study:

• To assess if a sequential strategy guided by molecular susceptibility testing improves H. pylori eradication rates compared to empirical therapy.
• To provide objective evidence on the value of PCR-based molecular methods in guiding H. pylori eradication.
• To evaluate the effectiveness of susceptibility-guided sequential therapy versus standard empirical treatment.

Main Methods:

• Prospective, randomized, open-label, active-controlled, single-center study.
• 500 H. pylori-positive, treatment-naïve participants (18-65 years) randomized to empirical or susceptibility-guided therapy.
• Regimen selection based on H. pylori susceptibility to clarithromycin and levofloxacin for guided therapy; bismuth quadruple therapy for empirical first-line.

Main Results:

• Primary outcome: first-line H. pylori eradication rate in both groups.
• Secondary outcome: overall H. pylori eradication rate (including rescue therapies).
• Analysis by intention-to-treat, modified intention-to-treat, and per-protocol.

Conclusions:

• This trial will offer valid evidence on the utility of PCR-based molecular susceptibility testing for H. pylori eradication.
• Results will inform clinical practice regarding the optimal approach for treating H. pylori infections.
• The study addresses the need for improved H. pylori treatment strategies in the face of rising antibiotic resistance.