Abstract
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 × 108 CFU, 7 times per day, or matching placebo plus 20 mg pantoprazole b.i.d. for 4 weeks. Cure was defined by negative 13C-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.
Highlights
Probiotics are defined as live microorganisms which, when administered in adequate amounts, confer a health benefit on the host
One of the most common research questions has been to investigate whether the addition of probiotics to traditional triple H. pylori eradication therapy would increase the cure rate. e studies have typically involved populations which have increased antimicrobial resistance resulting in a reduced cure rate, which provided the ability to identify whether the addition of a probiotic results in improvement. e results of these studies have been summarized by meta-analyses, a number of which have been published in the last 2 years [2,3,4,5,6,7,8]
Study Goal. e goal was to confirm that L. reuteri plus a PPI could cure H. pylori infections. e primary goal was to test whether increasing the total probiotic dose by decreasing the dosing interval plus a PPI could achieve a clinically acceptable cure rate (e.g., >50%)
Summary
Probiotics are defined as live microorganisms which, when administered in adequate amounts, confer a health benefit on the host. One of the most common research questions has been to investigate whether the addition of probiotics to traditional triple H. pylori eradication therapy would increase the cure rate. E studies have typically involved populations which have increased antimicrobial resistance resulting in a reduced cure rate, which provided the ability to identify whether the addition of a probiotic results in improvement. It shows that the, in the trials cited, the proportion with resistance was approximately 28%. Probiotics can reliably increase the cure rate to ≥90% only in regimens achieving cure rates of ∼80%. is trial is registered with NCT03404440
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