Twice-a-day PPI, tetracycline, metronidazole quadruple therapy with Pylera® or Lactobacillus reuteri for treatment naïve or for retreatment of Helicobacter pylori. Two randomized pilot studies.

Abstract

Bismuth is no longer available in Europe except as part of combination therapy. Lactobacillus reuteri has also been used as an adjuvant for Helicobacter pylori therapy. We aimed to investigate the efficacy of a b.i.d. quadruple therapy containing Pylera® or Lreuteri for Hpylori infection. We performed two open-label randomized pilot studies. Adult patients positive for Hpylori were randomly assigned to b.i.d therapy with quadruple therapy containing bismuth (2 capsules of Pylera® plus 250mg each of tetracycline and metronidazole for a total of 500mg of each), or the same dose of antibiotics plus 2×108 CFU Lreuteri DSM 17938 plus 2×108 CFU Lreuteri ATCC PTA 6475 (Gastrus®) once daily and pantoprazole 20mg b.i.d. Regimens were given with meals for 10days. Cure was defined by negative 13C-UBT or stool antigen test. A total of 99 subjects (29% men) were enrolled; 92 completed the study. In the Pylera® group, Hpylori infection was cured in 95.7%; 95% CI=85%-99% (44/46) PP and 88%; 95% CI=75%-95% (44/50) ITT vs. 84.8%; 95% CI=71%-95% (39/46) PP and 79.6%; 95% CI=65%-89% (39/49) ITT in the Gastrus® group, respectively. Cure rates in naїve patients were 100%; 95% CI=85%-100% (25/25) PP with Pylera®, and 89.7%; 95% CI=72%-97% (26/29) with Gastrus®. Compliance was excellent and side effects mild with both regimens. B.i.d. bismuth quadruple therapy was highly effective for Hpylori eradication in treatment of naïve patients in Sardinia. Replacement of bismuth with Gastrus® might be considered when bismuth is contraindicated or unavailable.