The PRO Health Study is a single-center, prospective, double-blind, randomized, placebo-controlled trial of streptococcus-containing supplementation in healthy adults.
Upon enrollment, healthy adults will enter a 1-week lead-in period which serves as an opportunity to collect baseline saliva samples and complete daily logs. Subjects that meet eligibility criteria on Day 7 will be randomized into 1 of 2 groups, receiving either a placebo-control or a streptococcus-containing probiotic supplement. Supplementation will begin on Day 8 and will continue for a total of 14 consecutive days. Participants will be observed for an additional 2 weeks following cessation of supplementation. The total duration of the study will be approximately 5 weeks. Saliva samples will be collected on 7 occasions and participants will be asked to complete questionnaires and daily diet and health logs throughout the course of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
26
A once-daily oral dose of the placebo-control supplement will be consumed by adults for 14 consecutive days.
A once-daily oral dose of the streptococcus-containing probiotic supplement will be consumed by adults for 14 consecutive days.
University of California, Davis
Davis, California, United States
Oral Streptococci levels in adults at 22 days - difference between S. Salivarius and placebo
The difference in levels of oral Streptococci between a streptococcus-containing probiotic supplement (e.g., S. salivarius K12) and placebo-control supplement on Day 22.
Time frame: 22 Days
Oral Streptococcus levels
The difference in levels of Streptococci upon intake of a streptococcus-containing probiotic supplement (e.g., S. salivarius K12) before, during and after the intervention compared with a placebo-control supplement.
Time frame: Change from baseline, days 10, 14, 22, 28, 36
Oral microbiome
The difference in the salivary microbiome before, during and after intake of a streptococcus-containing probiotic supplement (e.g., S. salivarius K12) and placebo-control supplement.
Time frame: Change from baseline, days 10, 14, 22, 28, 36
Number of stools per day
The relationship between supplementation and number of stools per day.
Time frame: Change from baseline, days 10, 14, 22, 28, 36
Changes in stool consistency
The relationship between supplementation and number of stools per day, rated using the Bristol Stool Scale.
Time frame: Change from baseline, days 10, 14, 22, 28, 36
Changes in stool firmness
The relationship between supplementation and number of stools per day, rated using a continuous scale of 1 to 10 (1 = extremely watery, almost entirely liquid to 10 = extremely hard, difficult to pass).
Time frame: Change from baseline, days 10, 14, 22, 28, 36
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