Treatment of Helicobacter pylori infection using a novel antiadhesion compound (3′sialyllactose sodium salt). A double blind, placebo-controlled clinical study

Background and Aim. 3′ sialyllactose sodium salt (3′SL) is an oligosaccharide that occurs naturally in human and bovine milk. It can inhibit the adhesion of H. pylori to human epithelial cells in vitro. The aim of this study was to test whether this oligosaccharide can suppress or cure H. pylori colonization in vivo and to determine its safety in humans. Methods. Seventy-one consecutive dyspeptic patients with H. pylori infection documented by histology and ¹³C-Urea Breath Test (UBT) were initially recruited to this study. Patients with UBT values <15 were excluded, thus reducing the enrolment to 65 patients. They were given two different dosages of 3′SL (10 g or 20 g/day) in three daily administrations before meals or placebo for 4 weeks, according to a randomised double-blind protocol. A standardized ¹³C-UBT (using 100 mg of ¹³C labelled urea) was repeated in all patients at fixed intervals during treatment (at the end of weeks 1, 2 and 4) and 4 weeks after treatment withdrawal. Patients compliance and side-effects were evaluated at each weekly visit. Results. Five patients were excluded from the PP analysis due to violation of the protocol (noncompliance, lost to follow-up), whereas 61 patients completed correctly the study: 17 received 3′SL 10 g/day, 22 were treated with 3′SL 20 g/ day and 21 were given placebo. The three treatment groups did not significantly differ in demographic or clinical patient characteristics. No serious adverse events were observed during therapy in any of the three groups. No patients became UBT negative (<4) during or after treatment but UBT values decreased significantly during the study period in both treatment groups and placebo. Conclusions. Antiadhesive therapy was safe and well tolerated but did not suppress or cure H. pylori colonization in humans. The observed decrease in UBT values could be explained by a regression towards the mean effect.