The purpose of this study is to evaluate the safety of an oral probiotic in healthy individuals.
The oral cavity houses one of the most diverse microbiota in the human body. There are nearly 800 unique oral bacterial species identified with more species expected to be added with further sampling and identification. As with microbiota of other sites in the human body, a balanced oral microbiota is essential to maintaining the health of the human host. Streptococcus salivarius is a pioneer species that colonizes the human oral cavity from birth, and remains a predominant member of the commensal microbiota throughout life. This randomized, double-blind, placebo-controlled study is conducted to investigate the safety and tolerability of a Streptococcus salivarius DB-B5 strain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
64
Sachets containing Streptococcus salivarius DB-B5 will be dissolved in water and consumed by the participants (n=30) once daily for 4 weeks. The participants will consume 10 billion colony forming units (CFU) per day.
Sachets containing a placebo (probiotic carrier) will be dissolved in water and consumed by the participants (n=30) once daily for 4 weeks.
TKL Research, Inc.
Fair Lawn, New Jersey, United States
Reports of adverse events
Reports of adverse events will be collected and compared between the probiotic and placebo groups.
Time frame: 4 weeks
Change in gastrointestinal symptoms measured using the Gastrointestinal Symptom Rating Scale (GSRS)
Gastrointestinal tolerability to the test products will be assessed using the Gastrointestinal Symptom Rating Scale (GSRS). The GSRS is composed of 15 items covering 5 dimensions: Reflux, Abdominal pain, Indigestion, Diarrhea and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.
Time frame: 4 weeks
Occurrence of abnormal blood laboratory test results
Fasting blood samples will be collected at baseline and end-of-study visits to assess for changes in hematology parameters (complete blood count including differentials and platelets).
Time frame: 4 weeks
Occurrence of abnormal clinical chemistry parameters test results
Fasting blood samples will be collected at baseline and end-of-study visits to assess for changes in clinical chemistry parameters (basic metabolic panel, hepatic function panel).
Time frame: 4 weeks
Occurrence of abnormal urinalysis test results
Urine samples will be collected at baseline and end-of-study visits to assess for changes in standard urinalysis parameters (specific gravity, pH, ketones, glucose, blood, bilirubin, and leukocyte esterase).
Time frame: 4 weeks
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