Atopic DermatitisPhase 2/3NCT00298337
Use of Probiotic Bacteria in Prevention of Allergic Disease in Children 1999-2008
A Phase 2/3 study testing Mixture of probiotic bacteria and prebiotic oligosaccharide in people with Atopic Dermatitis and Food Hypersensitivity, run by University of Helsinki at 1 site in Finland.
Trial 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 Read more about this study
- Who is it for?
- Ages 37 to 42 weeks
- Conditions the study is for
- Atopic Dermatitis, Food Hypersensitivity, Allergic Rhinitis, Seasonal
- What is being tested?
- Mixture of probiotic bacteria and prebiotic oligosaccharide
- How many people
- Not given
- Where
- 1 siteFinland
- Study dates
- Oct 1999to Dec 2007
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 37 to 42 weeks
- All sexes
- Child
Who may be able to join
- mother or father fo child with doctor diagnoses allergic disease
Who cannot join
- prematurity, major malformations
Trial locations and contacts
1 site in 1 country.
Finland1 site
Helsinki University Central Hospital, Skin and Allergy Hospital
Helsinki, PO Box 160, 00029 HUS
About this study
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
- Conditions
- Atopic Dermatitis, Food Hypersensitivity, Allergic Rhinitis, Seasonal, Allergic Conjunctivitis, Asthma
- Being tested
- Mixture of probiotic bacteria and prebiotic oligosaccharide
- Medical subject headings
- Dermatitis, Atopic, Food Hypersensitivity, Rhinitis, Allergic, Seasonal, Conjunctivitis, Allergic, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixture of probiotic bacteria and prebiotic oligosaccharideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2006 (estimated)
- Study startOct 1999
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Investigators
- Erkki Savilahti, Professor, Study chair, Helsinki University Central Hospital, Hospital for Children and Adults, PO Box 281, 00029 HUS, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00298337
- Sponsor's protocol ID
- T101060058;T1040A0002;T110612
- Status last verified
- Mar 2006
- First submitted
- 1 Mar 2006
- Last updated
- 18 Oct 2006
- Results posted
- No
Publications
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.
PubMed 38687061Tarrant 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.
PubMed 37438187Korpela 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.
PubMed 34857814Kallio 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.
PubMed 30472801Korpela 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.
PubMed 30326954Savilahti 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.
PubMed 22093109Kukkonen 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.
PubMed 21771118Kukkonen 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.
PubMed 18595980
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Probiotic Bacteria in Prevention of Allergic Disease in Children 1999-2008
- ClinicalTrials.gov ID
- NCT00298337
- Acronym / sponsor ID
- T101060058;T1040A0002;T110612
- Conditions
- Atopic Dermatitis, Food Hypersensitivity, Allergic Rhinitis, Seasonal, Allergic Conjunctivitis, Asthma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Study start
- Oct 1999
- Study completion
- Dec 2007
- First posted
- 2 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 37 to 42 weeks
- Sex
- All
- Age groups
- Child
Key inclusion criteria (1 listed)
- mother or father fo child with doctor diagnoses allergic disease
Key exclusion criteria (1 listed)
- prematurity, major malformations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mixture of probiotic bacteria and prebiotic oligosaccharide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2006.
- Derived from this study: PubMed 38687061Kallio 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.
- Derived from this study: PubMed 37438187Tarrant 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.
- Derived from this study: PubMed 34857814Korpela 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.
- Derived from this study: PubMed 30472801Kallio 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.
- Derived from this study: PubMed 30326954Korpela 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.
- Derived from this study: PubMed 22093109Savilahti 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.
- Derived from this study: PubMed 21771118Kukkonen 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.
- Derived from this study: PubMed 18595980Kukkonen 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.
- Clinical trialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erkki Savilahti, Professor study chair
Helsinki University Central Hospital, Hospital for Children and Adults, PO Box 281, 00029 HUS, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Mixture of probiotic bacteria and prebiotic oligosaccharide in people with Atopic Dermatitis and Food Hypersensitivity, run by University of Helsinki at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00298337, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2006.