NCT00298337

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 1999

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2006

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

October 18, 2006

Status Verified

March 1, 2006

First QC Date

March 1, 2006

Last Update Submit

October 17, 2006

Conditions

Atopic DermatitisFood HypersensitivityAllergic Rhinitis, SeasonalAllergic ConjunctivitisAsthma

Interventions

Mixture of probiotic bacteria and prebiotic oligosaccharideDRUG

Eligibility Criteria

Age37 Weeks - 42 Weeks
Sexall
Age GroupsChild (0-17)

You may qualify if:

  • mother or father fo child with doctor diagnoses allergic disease

You may not qualify if:

  • prematurity, major malformations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Central Hospital, Skin and Allergy Hospital

Helsinki, PO Box 160, 00029 HUS, Finland

Location

Related Publications (8)

  • Kallio S, Jian C, Korpela K, Kukkonen AK, Salonen A, Savilahti E, Kuitunen M, M de Vos W. Early-life gut microbiota associates with allergic rhinitis during 13-year follow-up in a Finnish probiotic intervention cohort. Microbiol Spectr. 2024 Jun 4;12(6):e0413523. doi: 10.1128/spectrum.04135-23. Epub 2024 Apr 30.

    PMID: 38687061DERIVED

  • Tarrant I, Finlay BB. Human milk oligosaccharides: potential therapeutic aids for allergic diseases. Trends Immunol. 2023 Aug;44(8):644-661. doi: 10.1016/j.it.2023.06.003. Epub 2023 Jul 11.

    PMID: 37438187DERIVED

  • 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.

    PMID: 34857814DERIVED

  • 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.

    PMID: 30472801DERIVED

  • 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.

    PMID: 30326954DERIVED

  • 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.

    PMID: 22093109DERIVED

  • 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.

    PMID: 21771118DERIVED

  • 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.

    PMID: 18595980DERIVED

Related Links

MeSH Terms

Conditions

Dermatitis, AtopicFood HypersensitivityRhinitis, Allergic, SeasonalConjunctivitis, AllergicAsthma

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesConjunctivitisConjunctival DiseasesEye DiseasesBronchial DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • Erkki Savilahti, Professor

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 1, 2006

First Posted

March 2, 2006

Study Start

October 1, 1999

Study Completion

December 1, 2007

Last Updated

October 18, 2006

Record last verified: 2006-03

Locations

FI(1)