Food AllergyNCT00200928
Asthma, a Disease Due to a Lack of Bacterial Infections in Childhood.
A study testing BCG in people with Food Allergy and Atopic Dermatitis, run by The Netherlands Asthma Foundation at 1 site in Netherlands.
Trial summary
The degree of TH1-skewing by mycobacteria is controlles by NRAMP1 gene polymorphisms and related to the degree of inhibition of TH2-mediated disease. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Food Allergy, Atopic Dermatitis, Asthma
- What is being tested?
- BCG
- How many people
- 120 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 1999to Jul 2005
- Phase
- Interventional
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- high-risk was defined as either a mother or a father plus a sibling with present or past atopic disease.
Who cannot join
- maternal infection in the last week of pregnancy, the use of immunomodulatory drugs or antibiotics during pregnancy (mother) or directly post partum (newborn)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Wilhelmina Children's Hospital (UMCU)
Utrecht, Utrecht, 3508AB
About this study
The degree of TH1-skewing by mycobacteria is controlles by NRAMP1 gene polymorphisms and related to the degree of inhibition of TH2-mediated disease.
Read the detailed description
A randomised single blinded intervention study in high-risk newborns vaccinated at the age of 6 weeks with BCG or placebo.
Inclusion: high-risk was defined as either a mother or a father and a sibling with present or past atopic disease.
Exclusion: maternal infection in the last week of pregnancy, the use of immunomodulatory drugs or antibiotics during pregnancy (mother), the use of antibiotics directly post-partum (newborn)
- Conditions
- Food Allergy, Atopic Dermatitis, Asthma, Rhinitis
- Being tested
- BCG
- Keywords
- prospective, randomised, intervention, BCG, atopy
- Medical subject headings
- Food Hypersensitivity, Dermatitis, Atopic, Asthma, Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCGBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of atopic disease.
Secondary outcomes (1)
SCORAD, lung function, IgE, cytokine production by PBMNC's, NRAMP-polymorphisms.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 1999
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AllergyStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- The Netherlands Asthma Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Maarten O Hoekstra, MD PhD, Principal investigator, Wilhelmina Children's Hospital Utrecht (UMCU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00200928
- Sponsor's protocol ID
- 3.2.93.96.2
- Status last verified
- Apr 2006
- First submitted
- 12 Sep 2005
- Last updated
- 4 Apr 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma, a Disease Due to a Lack of Bacterial Infections in Childhood.
- ClinicalTrials.gov ID
- NCT00200928
- Acronym / sponsor ID
- 3.2.93.96.2
- Conditions
- Food Allergy, Atopic Dermatitis, Asthma, Rhinitis
- Keywords
- prospective, randomised, intervention, BCG, atopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- The Netherlands Asthma FoundationUniversity, hospital or other
- Study start
- Jan 1999
- Study completion
- Jul 2005
- First posted
- 20 Sep 2005 (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 degree of TH1-skewing by mycobacteria is controlles by NRAMP1 gene polymorphisms and related to the degree of inhibition of TH2-mediated disease.
Detailed description
A randomised single blinded intervention study in high-risk newborns vaccinated at the age of 6 weeks with BCG or placebo.
Inclusion: high-risk was defined as either a mother or a father and a sibling with present or past atopic disease.
Exclusion: maternal infection in the last week of pregnancy, the use of immunomodulatory drugs or antibiotics during pregnancy (mother), the use of antibiotics directly post-partum (newborn)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- high-risk was defined as either a mother or a father plus a sibling with present or past atopic disease.
Key exclusion criteria (1 listed)
- maternal infection in the last week of pregnancy, the use of immunomodulatory drugs or antibiotics during pregnancy (mother) or directly post partum (newborn)
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 |
|---|---|---|
| BCG | Biological | – |
Primary outcome
Incidence and severity of atopic disease.
1 secondary outcome
SCORAD, lung function, IgE, cytokine production by PBMNC's, NRAMP-polymorphisms.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2006.
- click for more information: Indiaan onderzoekLink 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.
Maarten O Hoekstra, MD PhD principal investigator
Wilhelmina Children's Hospital Utrecht (UMCU)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCG in people with Food Allergy and Atopic Dermatitis, run by The Netherlands Asthma Foundation at 1 site in Netherlands.
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: finished, as of the sponsor's last update on 4 Apr 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 Netherlands. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Incidence and severity of atopic disease.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2006.