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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
Healthy adults
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
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 Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are a healthy adult.
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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.
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You need to avoid eating raw onions, garlic, sauerkraut, pickles, miso, and kimchi during the five-week study period.
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You agree not to use illegal drugs during the five-week study.
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You agree not to smoke cigarettes, chew tobacco, or use marijuana during the five-week study.
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You need to avoid eating foods like probiotics, kombucha, or yogurt during the five-week study.
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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.

PRO Health Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline, days 10, 14, 22, 28, 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline, days 10, 14, 22, 28, 36 for reporting.

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 more

PRO 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.

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor
908 Previous Clinical Trials
4,704,089 Total Patients Enrolled
Renew Life Formulas IncIndustry Sponsor
1 Previous Clinical Trials
81 Total Patients Enrolled

Media Library

Placebo-Control Supplement Clinical Trial Eligibility Overview. Trial Name: NCT03748017 — N/A
Oral Microbiome Research Study Groups: Placebo-Control Supplement, Streptococcus-Containing Probiotic Supplement
Oral Microbiome Clinical Trial 2023: Placebo-Control Supplement Highlights & Side Effects. Trial Name: NCT03748017 — N/A
Placebo-Control Supplement 2023 Treatment Timeline for Medical Study. Trial Name: NCT03748017 — N/A

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
Recent research and studies
~4 spots leftby Mar 2025