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

Sponsor:	University of Turku
Collaborators:	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)
Information provided by:	University of Turku
ClinicalTrials.gov Identifier:	NCT00638677

Purpose

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.

Condition	Intervention	Phase
Dental Caries Infectious Diseases	Dietary Supplement: Sorbitol Dietary Supplement: Xylitol + BB12 Dietary Supplement: Xylitol	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Bifidobacterium Lactis BB12 and Xylitol Delivered With a Novel Slow-release Pacifier

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements Diets

Drug Information available for: Sorbitol Xylitol

U.S. FDA Resources

Further study details as provided by University of Turku:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	150
Study Start Date:	June 2004
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Sorbitol tablet	Dietary Supplement: Sorbitol Sorbitol tablet delivered with a slow-release pacifier starting 1 mo after delivery and lasting max 2 years
2: Placebo Comparator Xylitol tablet	Dietary Supplement: Xylitol Xylitol+BB 12 delivery with a pacifier max until 2 years
3: Active Comparator Xylitol + BB12 tablet	Dietary Supplement: Xylitol + BB12 Xylitol + BB12 tablet delivered with a slow-release pacifier starting 1 mo after delivery and continuing max 2 years

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.

Eligibility

Ages Eligible for Study:	1 Month to 4 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00638677

Locations

Finland
Health Care Centre
Muurame and Korpilahti, Finland, 40950

Sponsors and Collaborators

University of Turku

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

Study Chair:

Pentti O Alanen, D.Odont

Professor, Inst. Dent. Univ. Turku

More Information

No publications provided

Responsible Party:	Inst. Dent. Univ. Turku ( Prof. Pentti Alanen )
Study ID Numbers:	Pacifierstudy20/8/2003, No ISRCTN or NIH grants
Study First Received:	March 12, 2008
Last Updated:	November 5, 2009
ClinicalTrials.gov Identifier:	NCT00638677 History of Changes
Health Authority:	Finland: Ethics Committee

Keywords provided by University of Turku:

Oral microbiology

Additional relevant MeSH terms:

Tooth Diseases
Communicable Diseases
Therapeutic Uses
Gastrointestinal Agents
Cathartics
Sorbitol

Stomatognathic Diseases
Infection
Pharmacologic Actions
Tooth Demineralization
Dental Caries

ClinicalTrials.gov processed this record on November 30, 2009