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

NCT ID: NCT00298337

Last Updated: 2006-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

1999-10-31

Study Completion Date

2007-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Atopic Dermatitis Food Hypersensitivity Allergic Rhinitis, Seasonal Allergic Conjunctivitis Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Mixture of probiotic bacteria and prebiotic oligosaccharide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* mother or father fo child with doctor diagnoses allergic disease

Exclusion Criteria

* prematurity, major malformations
Minimum Eligible Age

37 Weeks

Maximum Eligible Age

42 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Helsinki

OTHER

Sponsor Role lead

Principal Investigators

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Erkki Savilahti, Professor

Role: STUDY_CHAIR

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

Locations

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Helsinki University Central Hospital, Skin and Allergy Hospital

Helsinki, PO Box 160, Finland

Site Status

Countries

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Finland

References

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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.

Reference Type DERIVED
PMID: 38687061 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37438187 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34857814 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30472801 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30326954 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22093109 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21771118 (View on PubMed)

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.

Reference Type DERIVED
PMID: 18595980 (View on PubMed)

Related Links

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http://www.hus.fi

Clinical trials

Other Identifiers

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T101060058;T1040A0002;T110612

Identifier Type: -

Identifier Source: org_study_id