Summary

for people ages 21-45 (full criteria)
healthy people welcome
at UC Davis
study started
estimated completion:

Description

Summary

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

Details

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.

Keywords

Oral Microbiome Streptococcus-Containing Probiotic Supplement

Eligibility

You can join if…

Open to people ages 21-45

  • 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 (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

You CAN'T join if...

  • 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

Location

  • University of California, Davis accepting new patients
    Davis California 95616 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
ID
NCT03748017
Study Type
Interventional
Last Updated