Safety Clinical Trial
Official title:
To Demonstrate That a Novel Powder Formulation of Lactobacillus Reuteri DSM 17938 is Safe in Adults, a Randomized, Placebo Controlled Double-blind Study
Lactobacilli are commensal bacteria common to the gut of all mammals studied and
traditionally associated with foods are considered safe.The established safe use on a
diversity of foods and supplement products worldwide supports this conclusion. Lactobacillus
reuteri is one species of Lactobacillus that naturally inhabits the gastrointestinal tract
of humans and is one of the few autochthonous (indigenous) Lactobacillus species in infants
as well as adults.
Although the tolerability of DSM 17938 in a tablet formulation has earlier been established,
it is desirable to repeat the assessment in this novel formulation.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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