Clincosm LogoSign in Get a demo

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

Sponsor
University of Turku (Other)
Overall Status
Completed
CT.gov ID
NCT00638677
Collaborator
Chr Hansen (Industry), Fennobon oy, Karkkila, Finland (provides the tablets for the pacifier) (Other), Plastone Oy, Konnevesi, Finland (provides the pacifiers) (Other)
106
Enrollment
1
Location
3
Arms
98
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Sorbitol
  • Dietary Supplement: Xylitol + BB12
  • Dietary Supplement: Xylitol
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
106 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Bifidobacterium Lactis BB12 and Xylitol Delivered With a Novel Slow-release Pacifier
Study Start Date :
Jun 1, 2004
Actual Primary Completion Date :
Aug 1, 2012
Actual Study Completion Date :
Aug 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. MS colonization [2 years]

    Secondary Outcome Measures

    1. Acute infectious diseases [2 years]

    2. Caries occurrence [4 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month to 4 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Health Care Centre Muurame and Korpilahti Finland 40950

    Sponsors and Collaborators

    • University of Turku
    • Chr Hansen
    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eva Soderling, Associate professor, University of Turku
    ClinicalTrials.gov Identifier:
    NCT00638677
    Other Study ID Numbers:
    • Pacifierstudy20/8/2003
    • No ISRCTN or NIH grants
    First Posted:
    Mar 19, 2008
    Last Update Posted:
    Jan 8, 2013
    Last Verified:
    Jan 1, 2013
    Keywords provided by Eva Soderling, Associate professor, University of Turku
    Oral microbiology
    Additional relevant MeSH terms:
    Communicable Diseases
    Infections
    Dental Caries
    Sorbitol

    Study Results

    No Results Posted as of Jan 8, 2013