The Probiotic for Oral Health (PRO Health) Study (PRO Health)

November 27, 2023 updated by: University of California, Davis
The PRO Health Study is a single-center, prospective, double-blind, randomized, placebo-controlled trial of streptococcus-containing supplementation in healthy adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Davis, California, United States, 95616
        • University of California, Davis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy adults;
  • Age 21-45 years of age;
  • BMI between 18-30;
  • No history of infectious disease; heart, metabolic, autoimmune endocrine, liver, or kidney diseases; GI related conditions such as malabsorption disease, Crohn's disease, colitis, inflammatory bowel disease; Type 1 or 2 diabetes mellitus, any type of cancer, heart disease;
  • Practices good oral hygiene according to the American Dental Association with brushing teeth between 1-2 times per day;
  • Willingness to only use the study toothpaste to brush or clean teeth and refrain from using any other oral-care products such as other toothpaste, mouthwash, rinses and breath-sprays during the five-week study period;
  • Willingness to limit consumption of raw onions or garlic and fermented foods such as sauerkraut, pickles, miso, and kimchi during the five-week study period;
  • Non-alcohol consumers or those who consume alcohol in moderation defined as having up to 1 drink per day for women and up to 2 drinks per day for men;
  • Willingness to avoid binge drinking during the study period defined by the Centers for Disease Control and Prevention as: This pattern of drinking usually corresponds to 5 or more drinks on a single occasion for men or 4 or more drinks on a single occasion for women, generally within about 2 hours;
  • Willingness to refrain from drinking any alcohol within 24 hours of each saliva sample collection;
  • Willingness to refrain from using illicit drugs during the five-week study;
  • Willingness to refrain from using tobacco (smoking or chewing) or smoking marijuana during the five-week study period;
  • Willingness to refrain from intake of probiotics, kombucha, or yogurt during the five-week study period;
  • Willingness to refrain from consuming more than 1 package of sugary candy and from chewing more than 1 package of chewing gum during the five-week study period;
  • Willingness to refrain from having any non-emergency, elective oral surgeries, dental procedures or dental teeth cleanings during the five-week study period.

Exclusion Criteria:

  • Currently pregnant or plans to become pregnant several weeks prior to enrollment and during the five-week study period;
  • History of periodontal disease, or gingivitis;
  • Dental trauma or injury to the teeth and/or periodontium (gums, periodontal ligament, alveolar bone), and nearby soft tissues such as the lips, tongue within the past 4 weeks;
  • Any oral surgery or intensive procedures made to the oral cavity (such as fillings, wisdom tooth extraction, root canal, dental implants, etc.) within the past 4 weeks;
  • Routine dental cleaning within the past 4 weeks;
  • Use of probiotics, kombucha, or yogurt/kefir within the past 7 days of enrollment;
  • Use of probiotics containing S. salivarius within the past 8 weeks of enrollment;
  • Use of oral or IV antibiotics within the past 8 weeks of enrollment;
  • Consumption of more than one package of sugary candy (hard candy, gummy candy, mints, etc.) per day;
  • Use of more than one package of chewing gum (sugary or sugarless) per day;
  • Use of mouthwashes, mouth-rinses or breath-sprays more than three times per day;
  • Current tobacco (smoking or chewing) or E-cigarette users or individuals who quit using less than one year before enrolling in the study;
  • Frequent marijuana smoking or vaping, or use of other illicit drugs (must be no more than 12 times within the past year and no more than once per month);
  • Marijuana smoking or vaping or use of other illicit drugs within the past 4 weeks;
  • Excessive alcohol drinkers: For men, heavy drinking is typically defined as consuming 15 drinks or more per week. For women, heavy drinking is typically defined as consuming 8 drinks or more per week;
  • Individuals who live within the same household or who are in intimate relationships with current or past study participants (to avoid horizontal transfer of the oral microbiome);
  • Anyone the investigator feels isn't an applicable participant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo-Control Supplement
12 participants will receive a placebo-control supplement per daily oral feeding.
Dietary supplement: Placebo-Control Supplement
A once-daily oral dose of the placebo-control supplement will be consumed by adults for 14 consecutive days.
Active Comparator: Streptococcus-Containing Probiotic Supplement
12 participants will receive a powdered probiotic containing 7.77 billion colony-forming units (CFU) of L. acidophilus, 8.25 billion CFU of B. lactis, and 2 billion CFU of S. salivarius bacteriocin-like inhibitory substance (BLIS) K12 per daily oral feeding.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral Streptococci levels in adults at 22 days - difference between S. Salivarius and placebo
Time Frame: 22 Days
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.
22 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral Streptococcus levels
Time Frame: Change from baseline, days 10, 14, 22, 28, 36
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.
Change from baseline, days 10, 14, 22, 28, 36
Oral microbiome
Time Frame: Change from baseline, days 10, 14, 22, 28, 36
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.
Change from baseline, days 10, 14, 22, 28, 36
Number of stools per day
Time Frame: Change from baseline, days 10, 14, 22, 28, 36
The relationship between supplementation and number of stools per day.
Change from baseline, days 10, 14, 22, 28, 36
Changes in stool consistency
Time Frame: Change from baseline, days 10, 14, 22, 28, 36
The relationship between supplementation and number of stools per day, rated using the Bristol Stool Scale.
Change from baseline, days 10, 14, 22, 28, 36
Changes in stool firmness
Time Frame: Change from baseline, days 10, 14, 22, 28, 36
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).
Change from baseline, days 10, 14, 22, 28, 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

Renew Life Formulas Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2018

Primary Completion (Actual)

March 10, 2019

Study Completion (Actual)

October 1, 2021

Study Registration Dates

First Submitted

October 22, 2018

First Submitted That Met QC Criteria

November 16, 2018

First Posted (Actual)

November 20, 2018

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 1188050

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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