MedTrace Logo

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

NCT00638677 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2013-01-08

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Sorbitol

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

DIETARY_SUPPLEMENT

Xylitol + BB12

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

DIETARY_SUPPLEMENT

Xylitol

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

Sponsors & Collaborators

  • Chr Hansen

    collaborator INDUSTRY

  • Fennobon oy, Karkkila, Finland (provides the tablets for the pacifier)

    collaborator UNKNOWN

  • Plastone Oy, Konnevesi, Finland (provides the pacifiers)

    collaborator UNKNOWN

  • University of Turku

    lead OTHER

Principal Investigators

  • Eva M Söderling, PhD · Assoc. Prof., University of Turku

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
4 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • Finland

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00638677 on ClinicalTrials.gov