Oral MicrobiomePRO HealthNCT03748017
The Probiotic for Oral Health (PRO Health) Study
A study testing Streptococcus-Containing Probiotic Supplement in people with Oral Microbiome, run by University of California, Davis at 1 site in United States.
Trial summary
The PRO Health Study is a single-center, prospective, double-blind, randomized, placebo-controlled trial of streptococcus-containing supplementation in healthy adults. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Microbiome
- What is being tested?
- Streptococcus-Containing Probiotic Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2018to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis
Davis, California, 95616
About this study
The PRO Health Study is a single-center, prospective, double-blind, randomized, placebo-controlled trial of streptococcus-containing supplementation in healthy adults.
Read the 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.
- Conditions
- Oral Microbiome
- Being tested
- Placebo-Control Supplement, Streptococcus-Containing Probiotic Supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo-Control SupplementDietary supplement
A once-daily oral dose of the placebo-control supplement will be consumed by adults for 14 consecutive days.
Streptococcus-Containing Probiotic SupplementDietary supplement
A once-daily oral dose of the streptococcus-containing probiotic supplement will be consumed by adults for 14 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Placebo-Control Supplement | Placebo comparator | 12 participants will receive a placebo-control supplement per daily oral feeding. Receives: Dietary Supplement: Placebo-Control Supplement |
| Streptococcus-Containing Probiotic Supplement | Active comparator | 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. Receives: Dietary Supplement: Streptococcus-Containing Probiotic Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Streptococci levels in adults at 22 days - difference between S. Salivarius and placebo
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.
Measured: 22 Days
Secondary outcomes (5)
Oral Streptococcus levels
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.
Measured: Change from baseline, days 10, 14, 22, 28, 36
Oral microbiome
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.
Measured: Change from baseline, days 10, 14, 22, 28, 36
Number of stools per day
The relationship between supplementation and number of stools per day.
Measured: Change from baseline, days 10, 14, 22, 28, 36
Changes in stool consistency
The relationship between supplementation and number of stools per day, rated using the Bristol Stool Scale.
Measured: Change from baseline, days 10, 14, 22, 28, 36
Changes in stool firmness
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).
Measured: Change from baseline, days 10, 14, 22, 28, 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start4 Sep 2018
- Primary completion10 Mar 2019
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Oral MicrobiomeStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be enrolled and randomized, receiving either a streptococcus-containing probiotic supplement or a placebo-control supplement.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Renew Life Formulas Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03748017
- Sponsor's protocol ID
- 1188050
- Acronym
- PRO Health
- Status last verified
- Nov 2023
- First submitted
- 22 Oct 2018
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Horz HP, Meinelt A, Houben B, Conrads G. Distribution and persistence of probiotic Streptococcus salivarius K12 in the human oral cavity as determined by real-time quantitative polymerase chain reaction. Oral Microbiol Immunol. 2007 Apr;22(2):126-30. doi: 10.1111/j.1399-302X.2007.00334.x.
PubMed 17311636Upton M, Tagg JR, Wescombe P, Jenkinson HF. Intra- and interspecies signaling between Streptococcus salivarius and Streptococcus pyogenes mediated by SalA and SalA1 lantibiotic peptides. J Bacteriol. 2001 Jul;183(13):3931-8. doi: 10.1128/JB.183.13.3931-3938.2001.
PubMed 11395456Ross KF, Ronson CW, Tagg JR. Isolation and characterization of the lantibiotic salivaricin A and its structural gene salA from Streptococcus salivarius 20P3. Appl Environ Microbiol. 1993 Jul;59(7):2014-21. doi: 10.1128/aem.59.7.2014-2021.1993.
PubMed 8357242Cosseau C, Devine DA, Dullaghan E, Gardy JL, Chikatamarla A, Gellatly S, Yu LL, Pistolic J, Falsafi R, Tagg J, Hancock RE. The commensal Streptococcus salivarius K12 downregulates the innate immune responses of human epithelial cells and promotes host-microbe homeostasis. Infect Immun. 2008 Sep;76(9):4163-75. doi: 10.1128/IAI.00188-08. Epub 2008 Jul 14.
PubMed 18625732Di Pierro F, Adami T, Rapacioli G, Giardini N, Streitberger C. Clinical evaluation of the oral probiotic Streptococcus salivarius K12 in the prevention of recurrent pharyngitis and/or tonsillitis caused by Streptococcus pyogenes in adults. Expert Opin Biol Ther. 2013 Mar;13(3):339-43. doi: 10.1517/14712598.2013.758711. Epub 2013 Jan 4.
PubMed 23286823Di Pierro F, Colombo M, Zanvit A, Rottoli AS. Positive clinical outcomes derived from using Streptococcus salivarius K12 to prevent streptococcal pharyngotonsillitis in children: a pilot investigation. Drug Healthc Patient Saf. 2016 Nov 21;8:77-81. doi: 10.2147/DHPS.S117214. eCollection 2016.
PubMed 27920580Di Pierro F, Donato G, Fomia F, Adami T, Careddu D, Cassandro C, Albera R. Preliminary pediatric clinical evaluation of the oral probiotic Streptococcus salivarius K12 in preventing recurrent pharyngitis and/or tonsillitis caused by Streptococcus pyogenes and recurrent acute otitis media. Int J Gen Med. 2012;5:991-7. doi: 10.2147/IJGM.S38859. Epub 2012 Nov 30.
PubMed 23233809Di Pierro F, Colombo M, Giuliani MG, Danza ML, Basile I, Bollani T, Conti AM, Zanvit A, Rottoli AS. Effect of administration of Streptococcus salivarius K12 on the occurrence of streptococcal pharyngo-tonsillitis, scarlet fever and acute otitis media in 3 years old children. Eur Rev Med Pharmacol Sci. 2016 Nov;20(21):4601-4606.
PubMed 27874935Burton JP, Chilcott CN, Tagg JR. The rationale and potential for the reduction of oral malodour using Streptococcus salivarius probiotics. Oral Dis. 2005;11 Suppl 1:29-31. doi: 10.1111/j.1601-0825.2005.01084.x.
PubMed 15752094Burton JP, Chilcott CN, Moore CJ, Speiser G, Tagg JR. A preliminary study of the effect of probiotic Streptococcus salivarius K12 on oral malodour parameters. J Appl Microbiol. 2006 Apr;100(4):754-64. doi: 10.1111/j.1365-2672.2006.02837.x.
PubMed 16553730Bourdichon F, Casaregola S, Farrokh C, Frisvad JC, Gerds ML, Hammes WP, Harnett J, Huys G, Laulund S, Ouwehand A, Powell IB, Prajapati JB, Seto Y, Ter Schure E, Van Boven A, Vankerckhoven V, Zgoda A, Tuijtelaars S, Hansen EB. Food fermentations: microorganisms with technological beneficial use. Int J Food Microbiol. 2012 Mar 15;154(3):87-97. doi: 10.1016/j.ijfoodmicro.2011.12.030. Epub 2011 Dec 31.
PubMed 22257932Authority, 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Probiotic for Oral Health (PRO Health) Study
- ClinicalTrials.gov ID
- NCT03748017
- Acronym / sponsor ID
- PRO Health / 1188050
- Conditions
- Oral Microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Renew Life Formulas Inc
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 10 Mar 2019 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 20 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The PRO Health Study is a single-center, prospective, double-blind, randomized, placebo-controlled trial of streptococcus-containing supplementation in healthy adults.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be enrolled and randomized, receiving either a streptococcus-containing probiotic supplement or a placebo-control supplement.
| Arm | Type | Receives |
|---|---|---|
| Placebo-Control Supplement | Placebo comparator | Dietary Supplement: Placebo-Control Supplement12 participants will receive a placebo-control supplement per daily oral feeding. |
| Streptococcus-Containing Probiotic Supplement | Active comparator | Dietary Supplement: Streptococcus-Containing Probiotic Supplement12 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. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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;
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo-Control SupplementA once-daily oral dose of the placebo-control supplement will be consumed by adults for 14 consecutive days. | Dietary supplement | Placebo-Control Supplement |
| Streptococcus-Containing Probiotic SupplementA once-daily oral dose of the streptococcus-containing probiotic supplement will be consumed by adults for 14 consecutive days. | Dietary supplement | Streptococcus-Containing Probiotic Supplement |
Primary outcome
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.
5 secondary outcomes
Oral Streptococcus levels
Time frame: Change from baseline, days 10, 14, 22, 28, 36
Oral microbiome
Time frame: 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
Changes in stool consistency
Time frame: Change from baseline, days 10, 14, 22, 28, 36
Changes in stool firmness
Time frame: Change from baseline, days 10, 14, 22, 28, 36
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Background: PubMed 17311636Horz HP, Meinelt A, Houben B, Conrads G. Distribution and persistence of probiotic Streptococcus salivarius K12 in the human oral cavity as determined by real-time quantitative polymerase chain reaction. Oral Microbiol Immunol. 2007 Apr;22(2):126-30. doi: 10.1111/j.1399-302X.2007.00334.x.
- Background: PubMed 11395456Upton M, Tagg JR, Wescombe P, Jenkinson HF. Intra- and interspecies signaling between Streptococcus salivarius and Streptococcus pyogenes mediated by SalA and SalA1 lantibiotic peptides. J Bacteriol. 2001 Jul;183(13):3931-8. doi: 10.1128/JB.183.13.3931-3938.2001.
- Background: PubMed 8357242Ross KF, Ronson CW, Tagg JR. Isolation and characterization of the lantibiotic salivaricin A and its structural gene salA from Streptococcus salivarius 20P3. Appl Environ Microbiol. 1993 Jul;59(7):2014-21. doi: 10.1128/aem.59.7.2014-2021.1993.
- Background: PubMed 18625732Cosseau C, Devine DA, Dullaghan E, Gardy JL, Chikatamarla A, Gellatly S, Yu LL, Pistolic J, Falsafi R, Tagg J, Hancock RE. The commensal Streptococcus salivarius K12 downregulates the innate immune responses of human epithelial cells and promotes host-microbe homeostasis. Infect Immun. 2008 Sep;76(9):4163-75. doi: 10.1128/IAI.00188-08. Epub 2008 Jul 14.
- Background: PubMed 23286823Di Pierro F, Adami T, Rapacioli G, Giardini N, Streitberger C. Clinical evaluation of the oral probiotic Streptococcus salivarius K12 in the prevention of recurrent pharyngitis and/or tonsillitis caused by Streptococcus pyogenes in adults. Expert Opin Biol Ther. 2013 Mar;13(3):339-43. doi: 10.1517/14712598.2013.758711. Epub 2013 Jan 4.
- Background: PubMed 27920580Di Pierro F, Colombo M, Zanvit A, Rottoli AS. Positive clinical outcomes derived from using Streptococcus salivarius K12 to prevent streptococcal pharyngotonsillitis in children: a pilot investigation. Drug Healthc Patient Saf. 2016 Nov 21;8:77-81. doi: 10.2147/DHPS.S117214. eCollection 2016.
- Background: PubMed 23233809Di Pierro F, Donato G, Fomia F, Adami T, Careddu D, Cassandro C, Albera R. Preliminary pediatric clinical evaluation of the oral probiotic Streptococcus salivarius K12 in preventing recurrent pharyngitis and/or tonsillitis caused by Streptococcus pyogenes and recurrent acute otitis media. Int J Gen Med. 2012;5:991-7. doi: 10.2147/IJGM.S38859. Epub 2012 Nov 30.
- Background: PubMed 27874935Di Pierro F, Colombo M, Giuliani MG, Danza ML, Basile I, Bollani T, Conti AM, Zanvit A, Rottoli AS. Effect of administration of Streptococcus salivarius K12 on the occurrence of streptococcal pharyngo-tonsillitis, scarlet fever and acute otitis media in 3 years old children. Eur Rev Med Pharmacol Sci. 2016 Nov;20(21):4601-4606.
- Background: PubMed 15752094Burton JP, Chilcott CN, Tagg JR. The rationale and potential for the reduction of oral malodour using Streptococcus salivarius probiotics. Oral Dis. 2005;11 Suppl 1:29-31. doi: 10.1111/j.1601-0825.2005.01084.x.
- Background: PubMed 16553730Burton JP, Chilcott CN, Moore CJ, Speiser G, Tagg JR. A preliminary study of the effect of probiotic Streptococcus salivarius K12 on oral malodour parameters. J Appl Microbiol. 2006 Apr;100(4):754-64. doi: 10.1111/j.1365-2672.2006.02837.x.
- Background: PubMed 22257932Bourdichon F, Casaregola S, Farrokh C, Frisvad JC, Gerds ML, Hammes WP, Harnett J, Huys G, Laulund S, Ouwehand A, Powell IB, Prajapati JB, Seto Y, Ter Schure E, Van Boven A, Vankerckhoven V, Zgoda A, Tuijtelaars S, Hansen EB. Food fermentations: microorganisms with technological beneficial use. Int J Food Microbiol. 2012 Mar 15;154(3):87-97. doi: 10.1016/j.ijfoodmicro.2011.12.030. Epub 2011 Dec 31.
- BackgroundAuthority, 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Streptococcus-Containing Probiotic Supplement in people with Oral Microbiome, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral Streptococci levels in adults at 22 days - difference between S. Salivarius and placebo (time frame: 22 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03748017, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.