Bifidobacterium Lactis BB12 and Xylitol Delivered With a Novel Slow-release Pacifier
2 other identifiers
interventional
106
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2004
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 12, 2008
CompletedFirst Posted
Study publicly available on registry
March 19, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedJanuary 8, 2013
January 1, 2013
8.2 years
March 12, 2008
January 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
MS colonization
2 years
Secondary Outcomes (2)
Acute infectious diseases
2 years
Caries occurrence
4 years
Study Arms (3)
1
PLACEBO COMPARATORSorbitol tablet
2
PLACEBO COMPARATORXylitol tablet
3
ACTIVE COMPARATORXylitol + BB12 tablet
Interventions
Sorbitol tablet delivered with a slow-release pacifier starting 1 mo after delivery and lasting max 2 years
Xylitol + BB12 tablet delivered with a slow-release pacifier starting 1 mo after delivery and continuing max 2 years
Xylitol+BB 12 delivery with a pacifier max until 2 years
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- The child is not healthy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Turkulead
- Chr Hansen A/Scollaborator
- Fennobon oy, Karkkila, Finland (provides the tablets for the pacifier)collaborator
- Plastone Oy, Konnevesi, Finland (provides the pacifiers)collaborator
Study Sites (1)
Health Care Centre
Muurame and Korpilahti, 40950, Finland
Related Publications (1)
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.
PMID: 23571819DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eva M Söderling, PhD
Assoc. Prof., University of Turku
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
March 12, 2008
First Posted
March 19, 2008
Study Start
June 1, 2004
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
January 8, 2013
Record last verified: 2013-01