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

January 7, 2013 updated by: Eva Soderling, University of Turku

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Muurame and Korpilahti, Finland, 40950
        • Health Care Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Sorbitol tablet
Dietary supplement: Sorbitol
Sorbitol tablet delivered with a slow-release pacifier starting 1 mo after delivery and lasting max 2 years
Other Names:
  • Xylitol
  • Bifidobacterium lactis
Placebo Comparator: 2
Xylitol tablet
Dietary supplement: Xylitol
Xylitol+BB 12 delivery with a pacifier max until 2 years
Other Names:
  • Bifidobacterium lactis
  • Sorbitol
Active Comparator: 3
Xylitol + BB12 tablet
Dietary supplement: Xylitol + BB12
Xylitol + BB12 tablet delivered with a slow-release pacifier starting 1 mo after delivery and continuing max 2 years
Other Names:
  • Bifidobacterium lactis
  • Sorbitol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
MS colonization
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Acute infectious diseases
Time Frame: 2 years
2 years
Caries occurrence
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turku

Collaborators

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

Investigators

  • Principal Investigator: Eva M Söderling, PhD, Assoc. Prof., University of Turku

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

March 12, 2008

First Submitted That Met QC Criteria

March 12, 2008

First Posted (Estimate)

March 19, 2008

Study Record Updates

Last Update Posted (Estimate)

January 8, 2013

Last Update Submitted That Met QC Criteria

January 7, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pacifierstudy20/8/2003
  • No ISRCTN or NIH grants

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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