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Background   Meta-analyses involving >4000 subjects with probiotics added to antimicrobial  Helicobacter pylori  eradication therapy have reported a mean increase in the eradication rate of 12 to 14%. It is unclear how to translate that result into clinical practice.Aim   To evaluate whether administration of  Lactobacillus reuteri  plus a PPI without antibiotics would eradicate  H. pylori  infections.Methods   This was a double-blind placebo-controlled randomized 2-site study of  L. reuteri  (Gastrus®) at a dose of 2 × 10 8  CFU, 7 times per day, or matching placebo plus 20 mg pantoprazole b.i.d. for 4 weeks. Cure was defined by negative  13 C-UBT, 4 weeks after therapy. Sample size required ≥50% cure rates for using probiotics as a clinically useful monotherapy.Results   Recruitment was halted after 56 subjects because of the low cure rate; there were 8 dropouts; 48 subjects completed therapy (71% women, average age 49 years). The cure rates per protocol were 3/24 (12.5%; 95% CI 2.6–32%) with  L. reuteri  vs. 1/24 (4.1%) with placebo. Side effects (most often diarrhea) occurred infrequently (in 5/28 vs. 3/28; active vs. placebo therapy) ( P =0.53).Conclusion    L. reuteri  plus a PPI therapy was unable to provide a clinically important rate of  H. pylori  eradication. The cure rate albeit low (12.5%) was essentially identical to that achieved when probiotics were added to antibiotic therapy. The incremental improvement was additive and independent of antimicrobial resistance or antibiotics use. Probiotics can reliably increase the cure rate to ≥90% only in regimens achieving cure rates of ∼80%. This trial is registered with  NCT03404440 .

the canadian journal of infectious diseases and medical microbiology/canadian journal of infectious diseases and medical microbiology

Role of Probiotics in <i>Helicobacter pylori</i> Eradication: Lessons from a Study of <i>Lactobacillus reuteri</i> Strains DSM 17938 and ATCC PTA 6475 (Gastrus®) and a Proton-Pump Inhibitor

Role of Probiotics in Helicobacter pylori Eradication: Lessons from a Study of Lactobacillus reuteri Strains DSM 17938 and ATCC PTA 6475 (Gastrus®) and a Proton-Pump Inhibitor