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

Primary Purpose

Atopic Dermatitis, Food Hypersensitivity, Allergic Rhinitis, Seasonal

Status
Unknown status
Phase
Phase 2
Locations
Finland
Study Type
Interventional
Intervention
Mixture of probiotic bacteria and prebiotic oligosaccharide
Sponsored by
University of Helsinki
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atopic Dermatitis

Eligibility Criteria

37 Weeks - 42 Weeks (Child)All Sexes

Inclusion Criteria: mother or father fo child with doctor diagnoses allergic disease Exclusion Criteria: prematurity, major malformations

Sites / Locations

  • Helsinki University Central Hospital, Skin and Allergy Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 1, 2006
Last Updated
October 17, 2006
Sponsor
University of Helsinki
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1. Study Identification

Unique Protocol Identification Number
NCT00298337
Brief Title
Use of Probiotic Bacteria in Prevention of Allergic Disease in Children 1999-2008
Study Type
Interventional

2. Study Status

Record Verification Date
March 2006
Overall Recruitment Status
Unknown status
Study Start Date
October 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Helsinki

4. Oversight

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Food Hypersensitivity, Allergic Rhinitis, Seasonal, Allergic Conjunctivitis, Asthma

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Mixture of probiotic bacteria and prebiotic oligosaccharide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
37 Weeks
Maximum Age & Unit of Time
42 Weeks
Eligibility Criteria
Inclusion Criteria: mother or father fo child with doctor diagnoses allergic disease Exclusion Criteria: prematurity, major malformations
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erkki Savilahti, Professor
Organizational Affiliation
Helsinki University Central Hospital, Hospital for Children and Adults, PO Box 281, 00029 HUS, Finland
Official's Role
Study Chair
Facility Information:
Facility Name
Helsinki University Central Hospital, Skin and Allergy Hospital
City
Helsinki
State/Province
PO box 160
ZIP/Postal Code
00029 HUS
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
34857814
Citation
Korpela K, Kallio S, Salonen A, Hero M, Kukkonen AK, Miettinen PJ, Savilahti E, Kohva E, Kariola L, Suutela M, Tarkkanen A, de Vos WM, Raivio T, Kuitunen M. Gut microbiota develop towards an adult profile in a sex-specific manner during puberty. Sci Rep. 2021 Dec 2;11(1):23297. doi: 10.1038/s41598-021-02375-z.
Results Reference
derived
PubMed Identifier
30472801
Citation
Kallio S, Kukkonen AK, Savilahti E, Kuitunen M. Perinatal probiotic intervention prevented allergic disease in a Caesarean-delivered subgroup at 13-year follow-up. Clin Exp Allergy. 2019 Apr;49(4):506-515. doi: 10.1111/cea.13321. Epub 2018 Dec 18.
Results Reference
derived
PubMed Identifier
30326954
Citation
Korpela K, Salonen A, Vepsalainen O, Suomalainen M, Kolmeder C, Varjosalo M, Miettinen S, Kukkonen K, Savilahti E, Kuitunen M, de Vos WM. Probiotic supplementation restores normal microbiota composition and function in antibiotic-treated and in caesarean-born infants. Microbiome. 2018 Oct 16;6(1):182. doi: 10.1186/s40168-018-0567-4.
Results Reference
derived
PubMed Identifier
22093109
Citation
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.
Results Reference
derived
PubMed Identifier
21771118
Citation
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. doi: 10.1111/j.1365-2222.2011.03821.x. Epub 2011 Jul 19.
Results Reference
derived
PubMed Identifier
18595980
Citation
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. doi: 10.1542/peds.2007-1192.
Results Reference
derived
Links:
URL
http://www.hus.fi
Description
Clinical trials

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

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