Bifidobacterium Lactis BB12 and Xylitol Delivered With a Novel Slow-release Pacifier
Primary Purpose
Dental Caries, Infectious Diseases
Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Sorbitol
Xylitol + BB12
Xylitol
Sponsored by
About this trial
This is an interventional prevention trial for Dental Caries focused on measuring Oral microbiology
Eligibility 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
Sites / Locations
- Health Care Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Placebo Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
Sorbitol tablet
Xylitol tablet
Xylitol + BB12 tablet
Outcomes
Primary Outcome Measures
MS colonization
Secondary Outcome Measures
Acute infectious diseases
Caries occurrence
Full Information
NCT ID
NCT00638677
First Posted
March 12, 2008
Last Updated
January 7, 2013
Sponsor
University of Turku
Collaborators
Chr Hansen, Fennobon oy, Karkkila, Finland (provides the tablets for the pacifier), Plastone Oy, Konnevesi, Finland (provides the pacifiers)
1. Study Identification
Unique Protocol Identification Number
NCT00638677
Brief Title
Bifidobacterium Lactis BB12 and Xylitol Delivered With a Novel Slow-release Pacifier
Official Title
Bifidobacterium Lactis BB12 and Xylitol Delivered With a Novel Slow-release Pacifier
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turku
Collaborators
Chr Hansen, Fennobon oy, Karkkila, Finland (provides the tablets for the pacifier), Plastone Oy, Konnevesi, Finland (provides the pacifiers)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Infectious Diseases
Keywords
Oral microbiology
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Sorbitol tablet
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Xylitol tablet
Arm Title
3
Arm Type
Active Comparator
Arm Description
Xylitol + BB12 tablet
Intervention Type
Dietary Supplement
Intervention Name(s)
Sorbitol
Other Intervention Name(s)
Xylitol, Bifidobacterium lactis
Intervention Description
Sorbitol tablet delivered with a slow-release pacifier starting 1 mo after delivery and lasting max 2 years
Intervention Type
Dietary Supplement
Intervention Name(s)
Xylitol + BB12
Other Intervention Name(s)
Sorbitol, Bifidobacterium lactis
Intervention Description
Xylitol + BB12 tablet delivered with a slow-release pacifier starting 1 mo after delivery and continuing max 2 years
Intervention Type
Dietary Supplement
Intervention Name(s)
Xylitol
Other Intervention Name(s)
Sorbitol, Bifidobacterium lactis
Intervention Description
Xylitol+BB 12 delivery with a pacifier max until 2 years
Primary Outcome Measure Information:
Title
MS colonization
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Acute infectious diseases
Time Frame
2 years
Title
Caries occurrence
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva M Söderling, PhD
Organizational Affiliation
Assoc. Prof., University of Turku
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Care Centre
City
Muurame and Korpilahti
ZIP/Postal Code
40950
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
23571819
Citation
Taipale T, Pienihakkinen K, Alanen P, Jokela J, Soderling E. Administration of Bifidobacterium animalis subsp. lactis BB-12 in early childhood: a post-trial effect on caries occurrence at four years of age. Caries Res. 2013;47(5):364-72. doi: 10.1159/000348424. Epub 2013 Apr 5.
Results Reference
derived
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Bifidobacterium Lactis BB12 and Xylitol Delivered With a Novel Slow-release Pacifier
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