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Completed

NCT Number: NCT00638677

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

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.

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Key information

Conditions

Dental Caries Communicable Diseases Disease Attributes Infections Infectious Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

1 month–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Health Care Centre

Muurame and Korpilahti, 40950, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sorbitol

Dietary Supplement

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

Other names: Xylitol, Bifidobacterium lactis

Xylitol + BB12

Dietary Supplement

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

Other names: Sorbitol, Bifidobacterium lactis

Xylitol

Dietary Supplement

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

Other names: Sorbitol, Bifidobacterium lactis

Primary outcomes

  1. MS colonization

    Time frame: 2 years

Secondary outcomes

  1. Acute infectious diseases

    Time frame: 2 years

  2. Caries occurrence

    Time frame: 4 years

Sponsors and collaborators

Lead sponsor

University of Turku

Other

Collaborators

  • Fennobon oy, Karkkila, Finland (provides the tablets for the pacifier)
  • Novonesis
  • Plastone Oy, Konnevesi, Finland (provides the pacifiers)

Registry information

Important dates

Study start
2004
Primary completion
2012
Study completion
2012
First posted
Mar 19, 2008
Registry last updated
Jan 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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