NCT00638677

Bifidobacterium Lactis BB12 and Xylitol Delivered With a Novel Slow-release Pacifier

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: University of Turku · Academic / Other
• Sex: All
• Age: 1 Month – 4 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Dental Caries
• Infectious Diseases

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Sorbitol	Sorbitol tablet delivered with a slow-release pacifier starting 1 mo after delivery and lasting max 2 years
DIETARY_SUPPLEMENT	Xylitol + BB12	Xylitol + BB12 tablet delivered with a slow-release pacifier starting 1 mo after delivery and continuing max 2 years
DIETARY_SUPPLEMENT	Xylitol	Xylitol+BB 12 delivery with a pacifier max until 2 years

Timeline

• Start date: 2004-06-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2008-03-19
• Last updated: 2013-01-08

Locations

1 site across 1 country: Finland