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

Phase 4

Completed

• Conditions: Dental Caries; Infectious Diseases
• Interventions: Dietary Supplement: Xylitol + BB12; Dietary Supplement: Sorbitol; Dietary Supplement: Xylitol

• Registration Number: NCT00638677
• Lead Sponsor: University of Turku

Brief 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.

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2008-03-12
• Study First Submitted QC: 2008-03-12
• Study First Posted: 2008-03-19
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-07
• Last Update Posted: 2013-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Xylitol + BB12	Xylitol + BB12 tablet
1	Sorbitol	Sorbitol tablet
2	Xylitol	Xylitol tablet

Primary Outcome Measures

Name	Time	Method
MS colonization	2 years

Secondary Outcome Measures

Name	Time	Method
Acute infectious diseases	2 years
Caries occurrence	4 years

Trial Locations

Locations (1)

Health Care Centre; 🇫🇮 Muurame and Korpilahti, Finland