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

University of Turku

Status and phase: Completed; Phase 4

Conditions: Dental Caries; Infectious Diseases

Treatments: Dietary Supplement: Sorbitol; Dietary Supplement: Xylitol; Dietary Supplement: Xylitol + BB12

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00638677

No ISRCTN or NIH grants

Pacifierstudy20/8/2003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 patients

Sex: All

Ages: 1 month to 4 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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106 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Sorbitol tablet

Treatment:

Dietary Supplement: Sorbitol

2

Placebo Comparator group

Description:

Xylitol tablet

Treatment:

Dietary Supplement: Xylitol

3

Active Comparator group

Description:

Xylitol + BB12 tablet

Treatment:

Dietary Supplement: Xylitol + BB12