Safety and tolerance of Bacteroides xylanisolvens DSM 23964 in healthy adults.

We recently presented the strain Bacteroides xylanisolvens DSM 23964 to be safe for use in food. In order to confirm the tolerance of healthy humans to a regular oral intake of the strain B. xylanisolvens DSM 23964, we here report on the safety data of two successive human studies: a randomised and double-blind parallel group-controlled pilot study with 41 volunteers receiving a daily dose of a pasteurised fermented milk product containing up to 8.5×1011B. xylanisolvens DSM 23964 cells for 3 weeks, and a randomised and placebo-controlled double-blind major study with 140 volunteers receiving the same product but spray-dried and containing up to 1012 cells for 6 weeks. In both studies no persistent side effects of any kind were reported. The measured haematological parameters, and the serum concentrations of immunoglobulin and of inflammatory markers (IL-6, CRP, IFN-γ) were unaffected by the supplementation in both studies. A small decrease in the phagocytic activity of granulocytes and a small increase of TNF-α detected in the pilot study were both invalidated by the major study. This study further revealed that the supplementation induced no modification in natural killer cell activity and in liver enzyme values (gamma-glutamyl-transferase, glutamate-oxalacetate transaminase, glutamate-pyruvate transaminase). Our results definitively demonstrate that the pasteurised B. xylanisolvens DSM 23964 strain is safe and well tolerated by healthy human individuals.

RCT Entities:   Population Interventions Outcomes