Use of Probiotic Bacteria in Prevention of Allergic Disease in Children 1999-2008

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2006 by Helsinki University.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Helsinki University

ClinicalTrials.gov Identifier:

NCT00298337

First received: March 1, 2006

Last updated: October 17, 2006

Last verified: March 2006

History of Changes

Purpose

The aim of the study is to find out if allergic diseases can be prevented buy giving probiotic bacteria to pregnant mothers and their newborn infants

Condition	Intervention	Phase
Atopic Dermatitis Food Hypersensitivity Allergic Rhinitis, Seasonal Allergic Conjunctivitis Asthma	Drug: Mixture of probiotic bacteria and prebiotic oligosaccharide	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention

Resource links provided by NLM:

MedlinePlus related topics: Allergy Asthma Food Allergy Pinkeye

U.S. FDA Resources

Further study details as provided by Helsinki University:

Study Start Date:	October 1999
Estimated Study Completion Date:	December 2007

Eligibility

Ages Eligible for Study:	37 Weeks to 42 Weeks
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

mother or father fo child with doctor diagnoses allergic disease

Exclusion Criteria:

prematurity, major malformations

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00298337

Locations

Finland
Helsinki University Central Hospital, Skin and Allergy Hospital
Helsinki, PO box 160, Finland, 00029 HUS

Sponsors and Collaborators

Helsinki University

Investigators

Study Chair:

Erkki Savilahti, Professor

Helsinki University Central Hospital, Hospital for Children and Adults, PO Box 281, 00029 HUS, Finland

More Information

Additional Information:

Clinical trials This link exits the ClinicalTrials.gov site

No publications provided by Helsinki University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Savilahti EM, Kukkonen AK, Haahtela T, Tuure T, Kuitunen M, Savilahti E. Intestinal defensin secretion in infancy is associated with the emergence of sensitization and atopic dermatitis. Clin Exp Allergy. 2012 Mar;42(3):405-11. doi: 10.1111/j.1365-2222.2011.03904.x. Epub 2011 Nov 16.

Kukkonen AK, Savilahti EM, Haahtela T, Savilahti E, Kuitunen M. Ovalbumin-specific immunoglobulins A and G levels at age 2 years are associated with the occurrence of atopic disorders. Clin Exp Allergy. 2011 Oct;41(10):1414-21. Epub 2011 Jul 19.

Kukkonen K, Savilahti E, Haahtela T, Juntunen-Backman K, Korpela R, Poussa T, Tuure T, Kuitunen M. Long-term safety and impact on infection rates of postnatal probiotic and prebiotic (synbiotic) treatment: randomized, double-blind, placebo-controlled trial. Pediatrics. 2008 Jul;122(1):8-12.

ClinicalTrials.gov Identifier:	NCT00298337 History of Changes
Other Study ID Numbers:	T101060058;T1040A0002;T110612
Study First Received:	March 1, 2006
Last Updated:	October 17, 2006
Health Authority:	Finland: Ethics Committee

Additional relevant MeSH terms:

Asthma
Conjunctivitis
Conjunctivitis, Allergic
Dermatitis
Dermatitis, Atopic
Food Hypersensitivity
Rhinitis, Allergic, Seasonal
Hypersensitivity
Rhinitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases

Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Conjunctival Diseases
Eye Diseases
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on May 21, 2013

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