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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00638677
Enrollment
106
Registered
2008-03-19
Start date
2004-06-30
Completion date
2012-08-31
Last updated
2013-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries, Infectious Diseases

Keywords

Oral microbiology

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.

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.

Interventions

DIETARY_SUPPLEMENTSorbitol

Sorbitol tablet delivered with a slow-release pacifier starting 1 mo after delivery and lasting max 2 years

DIETARY_SUPPLEMENTXylitol + BB12

Xylitol + BB12 tablet delivered with a slow-release pacifier starting 1 mo after delivery and continuing max 2 years

DIETARY_SUPPLEMENTXylitol

Xylitol+BB 12 delivery with a pacifier max until 2 years

Sponsors

Chr Hansen
CollaboratorINDUSTRY
Fennobon oy, Karkkila, Finland (provides the tablets for the pacifier)
CollaboratorUNKNOWN
Plastone Oy, Konnevesi, Finland (provides the pacifiers)
CollaboratorUNKNOWN
University of Turku
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Months to 4 Years
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

Design outcomes

Primary

MeasureTime frame
MS colonization2 years

Secondary

MeasureTime frame
Acute infectious diseases2 years
Caries occurrence4 years

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026