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Probiotic Supplement for Oral Microbiome (PRO Health Trial)
N/A
Waitlist Available
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline, days 10, 14, 22, 28, 36
Awards & highlights
PRO Health Trial Summary
This trial is testing whether or not a streptococcus-containing supplement is effective in healthy adults. The trial is double-blind, meaning that neither the participants nor the researchers will know who is receiving the supplement or the placebo until the trial is over.
PRO Health Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline, days 10, 14, 22, 28, 36
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline, days 10, 14, 22, 28, 36
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Oral Streptococci levels in adults at 22 days - difference between S. Salivarius and placebo
Secondary outcome measures
Changes in stool consistency
Changes in stool firmness
Number of stools per day
+2 morePRO Health Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Streptococcus-Containing Probiotic SupplementActive Control1 Intervention
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.
Group II: Placebo-Control SupplementPlacebo Group1 Intervention
12 participants will receive a placebo-control supplement per daily oral feeding.
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Who is running the clinical trial?
University of California, DavisLead Sponsor
914 Previous Clinical Trials
4,720,812 Total Patients Enrolled
Renew Life Formulas IncIndustry Sponsor
1 Previous Clinical Trials
81 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had recent damage or injury to your teeth, gums, or nearby soft tissues within the past month.You have taken probiotics with S. salivarius in the last 8 weeks before joining the study.You are a healthy adult.You have used marijuana, vaped, or used other illegal drugs in the past month.You use mouthwashes, mouth-rinses, or breath-sprays more than three times a day.You agree not to use illegal drugs during the five-week study.You need to avoid eating foods like probiotics, kombucha, or yogurt during the five-week study.You have taken probiotics, kombucha, yogurt, or kefir in the past week before joining the study.You have a history of gum disease or inflammation of the gums.You eat more than one package of sugary candy (like hard candy, gummy candy, or mints) every day.You chew more than one package of gum (with or without sugar) every day.You are currently smoking tobacco, using chewing tobacco, or using e-cigarettes. You must have quit using these products at least one year ago to participate in the study.You have smoked or vaped marijuana or used other illegal drugs more than 12 times in the past year, and not more than once per month.You agree not to drink excessively during the study. Excessive drinking means having 5 or more drinks at one time for men, or 4 or more drinks at one time for women, usually within about 2 hours.You need to avoid eating raw onions, garlic, sauerkraut, pickles, miso, and kimchi during the five-week study period.You agree not to smoke cigarettes, chew tobacco, or use marijuana during the five-week study.You agree not to eat more than one package of sugary candy or chew more than one package of gum during the five-week study.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo-Control Supplement
- Group 2: Streptococcus-Containing Probiotic Supplement
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who meets the qualifications to become an active participant in this research endeavor?
"Eligibility requirements for this trial include patients with an oral microbiome and aged between 21-45. 26 participants are to be recruited in total."
Answered by AI
Are elderly individuals within the specified age range being approved to join this trial?
"This clinical trial is allowing individuals aged 21 to 45 to partake in their research study."
Answered by AI
Is recruitment currently underway for this clinical experiment?
"Clinicaltrials.gov currently states that this trial is not enrolling patients, though it was initially posted on September 4th 2018 and last updated on the 28th of September 2022. Nevertheless, two separate medical trials are open to candidates at present."
Answered by AI
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