Bifidobacterium Lactis BB12 and Xylitol Delivered With a Novel Slow-release Pacifier
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|ClinicalTrials.gov Identifier: NCT00638677|
Recruitment Status : Completed
First Posted : March 19, 2008
Last Update Posted : January 8, 2013
- 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.
- Test in a clinical study how feasible the method is and to study how the intervention affects caries occurrence.
The administration of B. lactis BB12 and xylitol affects beneficially the dental health of the child.
|Condition or disease||Intervention/treatment||Phase|
|Dental Caries Infectious Diseases||Dietary Supplement: Sorbitol Dietary Supplement: Xylitol + BB12 Dietary Supplement: Xylitol||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Bifidobacterium Lactis BB12 and Xylitol Delivered With a Novel Slow-release Pacifier|
|Study Start Date :||June 2004|
|Primary Completion Date :||August 2012|
|Study Completion Date :||August 2012|
Placebo Comparator: 1
Dietary Supplement: Sorbitol
Sorbitol tablet delivered with a slow-release pacifier starting 1 mo after delivery and lasting max 2 years
Placebo Comparator: 2
Dietary Supplement: Xylitol
Xylitol+BB 12 delivery with a pacifier max until 2 years
Active Comparator: 3
Xylitol + BB12 tablet
Dietary Supplement: Xylitol + BB12
Xylitol + BB12 tablet delivered with a slow-release pacifier starting 1 mo after delivery and continuing max 2 years
- MS colonization [ Time Frame: 2 years ]
- Acute infectious diseases [ Time Frame: 2 years ]
- Caries occurrence [ Time Frame: 4 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00638677
|Health Care Centre|
|Muurame and Korpilahti, Finland, 40950|
|Principal Investigator:||Eva M Söderling, PhD||Assoc. Prof., University of Turku|