Primary Prevention of Atopic Disease by Perinatal Administration of Probiotics

NCT00200954 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2008-08-18

No results posted yet for this study

Summary

Administration of probiotics to pregnant women from an atopic family and subsequently to their high-risk newborns results in prevention of the incidence or in a decrease of the severity of atopic disease during infancy.

Conditions

Interventions

DIETARY_SUPPLEMENT

Probiotic bacteria

3 x 10e9 CFU of a mixture of probiotic bacteria, once daily to the pregnant mothers last 6 weeks of pregnancy.To their offspring during the first year of life.

DIETARY_SUPPLEMENT

Placebo

The placebo consists of the carrier of the probiotic bacteria mixture, i.e. rice starch and maltodextran

Sponsors & Collaborators

  • UMC Utrecht

    collaborator OTHER
  • The Netherlands Asthma Foundation

    lead OTHER

Principal Investigators

  • Maarten O Hoekstra, MD PhD · Wilhelmina Children's Hospital Utrecht (UMCU)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2007-12-31
Completion
2008-08-31

Countries

  • Netherlands

Study Locations

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Entities

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 NCT00200954 on ClinicalTrials.gov