Trial | NCT00638677  Report issue

Official Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    106
Aims:

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.

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.
Study Started
Jun 30
2004
Primary Completion
Aug 31
2012
Study Completion
Aug 31
2012
Last Update
Jan 08
2013
Estimate

Dietary Supplement Sorbitol

Sorbitol tablet delivered with a slow-release pacifier starting 1 mo after delivery and lasting max 2 years

  • Other names: Xylitol, Bifidobacterium lactis

Dietary Supplement Xylitol + BB12

Xylitol + BB12 tablet delivered with a slow-release pacifier starting 1 mo after delivery and continuing max 2 years

  • Other names: Sorbitol, Bifidobacterium lactis

Dietary Supplement Xylitol

Xylitol+BB 12 delivery with a pacifier max until 2 years

  • Other names: Sorbitol, Bifidobacterium lactis

1 Placebo Comparator

Sorbitol tablet

2 Placebo Comparator

Xylitol tablet

3 Active Comparator

Xylitol + BB12 tablet

Criteria 

Inclusion Criteria:

The infant is healthy
The family agrees to use the novel slow-release pacifier
The infant starts to use the pacifier before the age of 3 months

Exclusion Criteria:

The child is not healthy
No Results Posted