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| Name | Class |
|---|---|
| Renew Life Formulas Inc | INDUSTRY |
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The PRO Health Study is a single-center, prospective, double-blind, randomized, placebo-controlled trial of streptococcus-containing supplementation in healthy adults.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo-Control Supplement | Placebo Comparator | 12 participants will receive a placebo-control supplement per daily oral feeding. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo-Control Supplement | Dietary Supplement | A once-daily oral dose of the placebo-control supplement will be consumed by adults for 14 consecutive days. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 22 Days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline, days 10, 14, 22, 28, 36 |
| Oral microbiome |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis | Davis | California | 95616 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17311636 | Background | 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. | |
| 11395456 | Background |
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Subjects will be enrolled and randomized, receiving either a streptococcus-containing probiotic supplement or a placebo-control supplement.
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Participants, investigators, and data evaluators will be blinded to the treatment assignments.
| Streptococcus-Containing Probiotic Supplement | Dietary Supplement | A once-daily oral dose of the streptococcus-containing probiotic supplement will be consumed by adults for 14 consecutive days. |
|
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. |
| Change from baseline, days 10, 14, 22, 28, 36 |
| Number of stools per day | The relationship between supplementation and number of stools per day. | 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. | 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). | Change from baseline, days 10, 14, 22, 28, 36 |
| Upton 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. |
| 8357242 | Background | Ross 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. |
| 18625732 | Background | Cosseau 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. |
| 23286823 | Background | Di 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. |
| 27920580 | Background | Di 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. |
| 23233809 | Background | Di 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. |
| 27874935 | Background | Di 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. |
| 15752094 | Background | Burton 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. |
| 16553730 | Background | Burton 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. |
| 22257932 | Background | Bourdichon 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. |
| Background | 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. |
| Background | Mogensen, G., et al., Inventory of microoganisms with a documented history of use in food. 2002. |