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

Tracking Information

First Received Date ^ICMJE

March 12, 2008

Last Updated Date

November 5, 2009

Start Date ^ICMJE

June 2004

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Caries occurence [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00638677 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Acute infectious diseases [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Oral microbial colonization [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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 Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

Condition ^ICMJE

Dental Caries
Infectious Diseases

Intervention ^ICMJE

Dietary Supplement: Sorbitol
Dietary Supplement: Xylitol + BB12
Dietary Supplement: Xylitol

Study Arms / Comparison Groups

Placebo Comparator: Sorbitol tablet
Placebo Comparator: Xylitol tablet
Active Comparator: Xylitol + BB12 tablet

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

150

Estimated Completion Date

December 2012

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

1 Month to 4 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Finland

Administrative Information

NCT ID ^ICMJE

NCT00638677

Responsible Party

Prof. Pentti Alanen, Inst. Dent. Univ. Turku

Study ID Numbers ^ICMJE

Pacifierstudy20/8/2003, No ISRCTN or NIH grants

Study Sponsor ^ICMJE

University of Turku

Collaborators ^ICMJE

Muurame and Korpilahti Health Care Centre, Finland
Chr Hansen, Denmark (provides the BB 12)
Fennobon oy, Karkkila, Finland (provides the tablets for the pacifier)
Plastone Oy, Konnevesi, Finland (provides the pacifiers)

Investigators ^ICMJE

Study Chair:

Pentti O Alanen, D.Odont

Professor, Inst. Dent. Univ. Turku

Information Provided By

University of Turku

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP