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Aims: 1. To develop a food supplement containing a health-promoting probiotic bacteria (B. lactis BB12) and xylitol to be administered with a novel soft, possibly occlusion-friendly pacifier. 2. Test in a clinical study how feasible the method is and to study how the intervention affects caries occurrence. Main hypothesis: The administration of B. lactis BB12 and xylitol affects beneficially the dental health of the child.
Xylitol is known to reduce counts of mutans streptococci (ms) as well as mother-child transmission of ms. Possibly xylitol delivered to infants could positively influence colonization/metabolism of ms. By combining in a food supplement xylitol and B. lactis BB12 (a well known probiotic bacteria) we may be able to positively affect both gut and oral colonization, reflected in both dental and general health (solid data available on the latter aim). Though B. lactis is in wide use in baby formulas and in in vitro tests it apparently is safe for the teeth, no clinical studies have looked at effects of its administration to infants on oral health. Our study aims to look at caries occurrence in infants who have received the xylitol + BB12 food supplement with a pacifier. Recruiting of subjects to the study is completed.
Age
0 - 4 years
Sex
ALL
Healthy Volunteers
Yes
Health Care Centre
Muurame and Korpilahti, Finland
Start Date
June 1, 2004
Primary Completion Date
August 1, 2012
Completion Date
August 1, 2012
Last Updated
January 8, 2013
106
ACTUAL participants
Sorbitol
DIETARY_SUPPLEMENT
Xylitol + BB12
DIETARY_SUPPLEMENT
Xylitol
DIETARY_SUPPLEMENT
Lead Sponsor
University of Turku
Collaborators
NCT06430957
NCT07347015
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06787261