Quadruple therapy with lactoferrin for Helicobacter pylori eradication: a randomised, multicentre study

Area of Science:

• Gastroenterology
• Microbiology
• Pharmacology

Background:

• Decreasing efficacy of standard triple therapies for H. pylori eradication.
• Previous studies suggested lactoferrin enhances eradication with specific triple therapies.
• Need to evaluate lactoferrin's effect on other common H. pylori treatment regimens.

Purpose of the Study:

• To determine if lactoferrin increases H. pylori eradication rates.
• To assess lactoferrin's efficacy when added to a 7-day esomeprazole, clarithromycin, and amoxycillin triple therapy.
• To evaluate the safety and tolerability of the quadruple regimen.

Main Methods:

• Randomized controlled trial involving 133 patients with non-ulcer dyspepsia and H. pylori infection.
• Comparison of a 7-day standard triple therapy (esomeprazole, clarithromycin, amoxycillin) versus quadruple therapy (triple regimen plus lactoferrin).
• H. pylori status assessed by endoscopy and (13)C urea breath test post-treatment.

Main Results:

• H. pylori eradication rates were 77.9% (ITT) and 80.3% (PP) for triple therapy.
• Eradication rates were 76.9% (ITT) and 78.1% (PP) for quadruple therapy with lactoferrin.
• No statistically significant difference in cure rates or side effects between the two groups (p=0.9).

Conclusions:

• Lactoferrin-containing quadruple therapy did not significantly improve H. pylori cure rates compared to standard triple therapy.
• The addition of lactoferrin to clarithromycin-amoxycillin-based regimens is not effective in increasing eradication.
• Quadruple therapy with lactoferrin is a viable option with similar efficacy and tolerability to standard triple therapy.