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

This study has been completed.
Sponsor:
Collaborators:
Chr Hansen A/S
Fennobon oy, Karkkila, Finland (provides the tablets for the pacifier)
Plastone Oy, Konnevesi, Finland (provides the pacifiers)
Information provided by (Responsible Party):
Eva Soderling, University of Turku
ClinicalTrials.gov Identifier:
NCT00638677
First received: March 12, 2008
Last updated: January 7, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Dental Caries
Infectious Diseases
 Dietary Supplement: Sorbitol
Dietary Supplement: Xylitol + BB12
Dietary Supplement: Xylitol
 Phase 4

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

Resource links provided by NLM:

MedlinePlus related topics: Tooth Decay
U.S. FDA Resources

Further study details as provided by University of Turku:

Primary Outcome Measures:
  • MS colonization [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acute infectious diseases [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Caries occurrence [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Enrollment: 106
Study Start Date: June 2004
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Sorbitol tablet
 Dietary Supplement: Sorbitol
Sorbitol tablet delivered with a slow-release pacifier starting 1 mo after delivery and lasting max 2 years
Other Names:
  • Xylitol
  • Bifidobacterium lactis
Placebo Comparator: 2
Xylitol tablet
 Dietary Supplement: Xylitol
Xylitol+BB 12 delivery with a pacifier max until 2 years
Other Names:
  • Sorbitol
  • Bifidobacterium lactis
Active Comparator: 3
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
Other Names:
  • Sorbitol
  • Bifidobacterium lactis

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
Chr Hansen A/S
Fennobon oy, Karkkila, Finland (provides the tablets for the pacifier)
Plastone Oy, Konnevesi, Finland (provides the pacifiers)
Investigators
Principal Investigator: Eva M Söderling, PhD Assoc. Prof., University of Turku
  More Information

No publications provided

Responsible Party: Eva Soderling, Associate professor, University of Turku
ClinicalTrials.gov Identifier: NCT00638677     History of Changes
Other Study ID Numbers: Pacifierstudy20/8/2003, No ISRCTN or NIH grants
Study First Received: March 12, 2008
Last Updated: January 7, 2013
Health Authority: Finland: Ethics Committee

Keywords provided by University of Turku:
Oral microbiology

Additional relevant MeSH terms:
Communicable Diseases
Infection
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
 Sorbitol
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013