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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dental Caries, Infectious Diseases

Intervention / Treatment
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* Dietary Supplement: Sorbitol
* Dietary Supplement: Xylitol + BB12
* Dietary Supplement: Xylitol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Sorbitol tablet | Dietary Supplement: Sorbitol<br>* Sorbitol tablet delivered with a slow-release pacifier starting 1 mo after delivery and lasting max 2 years<br>* Other names: Bifidobacterium lactis;|
| Placebo Comparator: 2<br>Xylitol tablet | Dietary Supplement: Xylitol<br>* Xylitol+BB 12 delivery with a pacifier max until 2 years<br>* Other names: Bifidobacterium lactis;|
| Active Comparator: 3<br>Xylitol + BB12 tablet | Dietary Supplement: Xylitol + BB12<br>* Xylitol + BB12 tablet delivered with a slow-release pacifier starting 1 mo after delivery and continuing max 2 years<br>* Other names: Bifidobacterium lactis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MS colonization |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute infectious diseases |  | 2 years | 
| Caries occurrence |  | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral microbiology