Cow's Milk AllergyNCT00298376
Oral Tolerance in Cow's Milk Allergy in the Infant
An observational study of Cow's Milk Allergy, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
This study aims to determine if there is a link between cow's milk allergy in infants and regulatory T cells dysfunction that should be transient in infant acquiring oral tolerance after 12 month avoiding food and persistent in others. Read more about this study
- Who is it for?
- Ages 1 month to 15 monthsHealthy volunteers can take part
- Conditions the study is for
- Cow's Milk Allergy
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2006to not given
- Phase
- Observational
- 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 1 month to 15 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- male or female, age before 6 month, cow's milk allergy with positive prick or patch test for cow's milk
- Control group: male or female, age before 6 month or within 12 and 18 month, eating cow's milk every day
Who cannot join
- immunodeficiency syndrome, lactose intolerance Control group: other food allergy, atopic dermatitis.
Trial locations and contacts
1 site in 1 country.
Dominique KAISERLIAN, PhD contact
France1 site, 1 recruiting
- Recruiting
Alain Lachaux
Lyon, 69003
Alain LACHAUX, MD, 33 472 110 390, alain.lachaux@chu-lyon.fr
About this study
Official title: Oral Tolerance in Cow's Milk Allergy in the Infant: Role of CD4+CD25+ T Cells and Intestinal Microflora
This study aims to determine if there is a link between cow's milk allergy in infants and regulatory T cells dysfunction that should be transient in infant acquiring oral tolerance after 12 month avoiding food and persistent in others.
Cow's milk allergy is evaluated by basophils activation test, T cells activation test, specific humoral response (IgA, IgE, IgG) in allergic infants before and after 12 month avoiding food, before and after low dose milk exposure, before and after oral challenge.
Number and function of regulatory T cells and microflora composition are measured at the same time.
Allergic infants are compared to age matched control group.
- Conditions
- Cow's Milk Allergy
- Keywords
- Cow's milk allergy,, food allergy, oral tolerance,, infant,, regulatory T cells,, intestinal microflora
- Medical subject headings
- Milk Hypersensitivity, Food Hypersensitivity
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 startMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cow's Milk AllergyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Investigators
- Alain LACHAUX, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00298376
- Sponsor's protocol ID
- 2005.389
- Status last verified
- Apr 2007
- First submitted
- 1 Mar 2006
- Last updated
- 27 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Tolerance in Cow's Milk Allergy in the Infant: Role of CD4+CD25+ T Cells and Intestinal Microflora
- ClinicalTrials.gov ID
- NCT00298376
- Acronym / sponsor ID
- 2005.389
- Conditions
- Cow's Milk Allergy
- Keywords
- Cow's milk allergy,, food allergy, oral tolerance,, infant,, regulatory T cells,, intestinal microflora
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Mar 2006
- 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.
This study aims to determine if there is a link between cow's milk allergy in infants and regulatory T cells dysfunction that should be transient in infant acquiring oral tolerance after 12 month avoiding food and persistent in others.
Cow's milk allergy is evaluated by basophils activation test, T cells activation test, specific humoral response (IgA, IgE, IgG) in allergic infants before and after 12 month avoiding food, before and after low dose milk exposure, before and after oral challenge.
Number and function of regulatory T cells and microflora composition are measured at the same time.
Allergic infants are compared to age matched control group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 15 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- male or female, age before 6 month, cow's milk allergy with positive prick or patch test for cow's milk
- Control group: male or female, age before 6 month or within 12 and 18 month, eating cow's milk every day
Key exclusion criteria (1 listed)
- immunodeficiency syndrome, lactose intolerance Control group: other food allergy, atopic dermatitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 27 Apr 2007.
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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.
Dominique KAISERLIAN, PhD contact
Alain LACHAUX, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cow's Milk Allergy, run by Hospices Civils de Lyon at 1 site in France.
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 2 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 27 Apr 2007. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Florence VILLARD-TRUC, MD (33 472 110 390, fvillardtruc@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 27 Apr 2007.