NCT03748017

The Probiotic for Oral Health (PRO Health) Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 21 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The PRO Health Study is a single-center, prospective, double-blind, randomized, placebo-controlled trial of streptococcus-containing supplementation in healthy adults.

Detailed description

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.

Conditions

• Oral Microbiome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo-Control Supplement	A once-daily oral dose of the placebo-control supplement will be consumed by adults for 14 consecutive days.
DIETARY_SUPPLEMENT	Streptococcus-Containing Probiotic Supplement	A once-daily oral dose of the streptococcus-containing probiotic supplement will be consumed by adults for 14 consecutive days.

Timeline

• Start date: 2018-09-04
• Primary completion: 2019-03-10
• Completion: 2021-10-01
• First posted: 2018-11-20
• Last updated: 2023-11-28

Locations

1 site across 1 country: United States