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

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00638677
• Other study ID #: Pacifierstudy20/8/2003
• Secondary ID: No ISRCTN or NIH
• Status: Completed
• Phase: Phase 4
• First received: March 12, 2008
• Last updated: January 7, 2013
• Start date: June 2004
• Est. completion date: August 2012

Study information

• Verified date: January 2013
• Source: University of Turku
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Month to 4 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Dental Caries
• Infection
• Infectious Diseases

Intervention

Dietary Supplement:
• Sorbitol
Sorbitol tablet delivered with a slow-release pacifier starting 1 mo after delivery and lasting max 2 years
• Xylitol + BB12
Xylitol + BB12 tablet delivered with a slow-release pacifier starting 1 mo after delivery and continuing max 2 years
• Xylitol
Xylitol+BB 12 delivery with a pacifier max until 2 years

Locations

Country	Name	City	State
Finland	Health Care Centre	Muurame and Korpilahti

Sponsors (4)

Lead Sponsor	Collaborator
University of Turku	Chr Hansen A/S, Fennobon oy, Karkkila, Finland (provides the tablets for the pacifier), Plastone Oy, Konnevesi, Finland (provides the pacifiers)

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MS colonization		2 years	No
Secondary	Acute infectious diseases		2 years	No
Secondary	Caries occurrence		4 years	No