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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03748017
Recruitment Status : Active, not recruiting
First Posted : November 20, 2018
Last Update Posted : July 1, 2019
Sponsor:
Collaborator:
Renew Life Formulas Inc
Information provided by (Responsible Party):
University of California, Davis

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

Condition or disease Intervention/treatment Phase
Oral Microbiome Dietary Supplement: Placebo-Control Supplement Dietary Supplement: Streptococcus-Containing Probiotic Supplement Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be enrolled and randomized, receiving either a streptococcus-containing probiotic supplement or a placebo-control supplement.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Participants, investigators, and data evaluators will be blinded to the treatment assignments.
Primary Purpose: Basic Science
Official Title: The Probiotic for Oral Health (PRO Health) Study
Actual Study Start Date : September 4, 2018
Estimated Primary Completion Date : February 4, 2028
Estimated Study Completion Date : February 4, 2028

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 CDC 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748017


Locations
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United States, California
University of California, Davis
Davis, California, United States, 95616
Sponsors and Collaborators
University of California, Davis
Renew Life Formulas Inc
Publications:
Authority, E.F.S., Introduction of a Qualified Presumption of Safety (QPS) approach for assessment of selected microorganisms referred to EFSA‐Opinion of the Scientific Committee. EFSA Journal, 2007. 5(12): p. 587.
Mogensen, G., et al., Inventory of microoganisms with a documented history of use in food. 2002.

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03748017    
Other Study ID Numbers: 1188050
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No