Food HypersensitivityNCT01199484
Specific Oral Tolerance Induction to Cow's Milk Allergy
A study testing Cow's milk in people with Food Hypersensitivity, run by General University Hospital of Valencia at 1 site in Spain.
Trial summary
Background: Limited published evidence shows specific oral tolerance induction (SOTI) to be a potential intervention option for cow's milk proteins (CMPs) allergy. Our hypothesis is that SOTI should be started early in order to improve its efficacy and prevent CMPs sensitization from evolving towards persistent… Read more about this study
- Who is it for?
- Ages 24 to 36 months
- Conditions the study is for
- Food Hypersensitivity
- What is being tested?
- Cow's milk
- How many people
- Not given
- Where
- 1 siteSpain
- Study dates
- Start not givento not given
- 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 24 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- -Infants between 24-36 months of age.
- -IgE-mediated allergy to CMPs meeting all the following diagnostic criteria:
- Immediate-type clinical manifestations, skin (urticaria, angioedema and/or erythema), digestive (acute vomiting and/or diarrhea) or respiratory (bronchospasm and/or rhinitis) involvement in the first two hours after cow's milk ingestion.
- Skin test readings ≥ 3 mm and specific IgE titers > 0.35 kU/l for whole cow's milk or someone of isolated CMPs (casein, alpha-lactalbumin, beta-lactoglobulin )
- -Persistence of CMP allergy in the four weeks prior to tolerance induction, based on the following criteria:
- Skin (prick) test readings ≥3 mm and specific IgE titers (CAP-FEIA) >0.35 kU/l for whole cow's milk or someone of isolated CMPs (casein, alpha-lactalbumin, beta-lactoglobulin )
- Double-blind placebo-controlled challenge (DBPCFC) positive to cow's milk.
- -Written informed consent from the parents.
Who cannot join
- -Clinical manifestations of anaphylactic shock after the ingestion of cow's milk.
- -Non-IgE-mediated or non-immunological adverse reactions to cow's milk.
- -Malignant or immunopathological diseases and/or severe primary or secondary immune deficiencies.
- -Patients receiving immunosuppressor therapy.
- -Patients receiving beta-blockers (including topical formulations).
- -Associated diseases contraindicating the use of adrenalin: cardiovascular disease or severe hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Specific Oral Tolerance Induction as an Useful Treatment in Two-year-old Children With Cow's Milk Allergy.
Background: Limited published evidence shows specific oral tolerance induction (SOTI) to be a potential intervention option for cow's milk proteins (CMPs) allergy. Our hypothesis is that SOTI should be started early in order to improve its efficacy and prevent CMPs sensitization from evolving towards persistent allergy. The aim of this study was to evaluate the safety and efficacy of SOTI in 2-year-old children with cow's milk allergy, as a treatment alternative to elimination diet.
Methods: A total of 60 children between 24-36 months of age with IgE-mediated allergy to CMPs were included in this multicenter study and were randomly divided into two different groups. Thirty children (group A: treatment group) began SOTI immediately, whereas the remaining 30 (group B: control group) were kept on a milk-free diet and followed-up on for one year.
- Conditions
- Food Hypersensitivity
- Being tested
- Cow's milk
- Keywords
- Cow's milk allergy, food allergy, oral desensitization, randomized trial, specific oral tolerance induction.
- Medical subject headings
- Food Hypersensitivity, Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cow's milkOther
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food HypersensitivityStudies 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
Sponsor and investigators
- Lead sponsor
- General University Hospital of Valencia
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01199484
- Sponsor's protocol ID
- SOTI-CMA
- Status last verified
- Sep 2010
- First submitted
- 9 Sep 2010
- Last updated
- 13 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specific Oral Tolerance Induction as an Useful Treatment in Two-year-old Children With Cow's Milk Allergy.
- ClinicalTrials.gov ID
- NCT01199484
- Acronym / sponsor ID
- SOTI-CMA
- Conditions
- Food Hypersensitivity
- Keywords
- Cow's milk allergy, food allergy, oral desensitization, randomized trial, specific oral tolerance induction.
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- General University Hospital of ValenciaUniversity, hospital or other
- First posted
- 13 Sep 2010 (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.
Background: Limited published evidence shows specific oral tolerance induction (SOTI) to be a potential intervention option for cow's milk proteins (CMPs) allergy. Our hypothesis is that SOTI should be started early in order to improve its efficacy and prevent CMPs sensitization from evolving towards persistent allergy. The aim of this study was to evaluate the safety and efficacy of SOTI in 2-year-old children with cow's milk allergy, as a treatment alternative to elimination diet.
Methods: A total of 60 children between 24-36 months of age with IgE-mediated allergy to CMPs were included in this multicenter study and were randomly divided into two different groups. Thirty children (group A: treatment group) began SOTI immediately, whereas the remaining 30 (group B: control group) were kept on a milk-free diet and followed-up on for one year.
Study design
Who may qualify
- Ages
- 24 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- -Infants between 24-36 months of age.
- -IgE-mediated allergy to CMPs meeting all the following diagnostic criteria:
- -Persistence of CMP allergy in the four weeks prior to tolerance induction, based on the following criteria:
- -Written informed consent from the parents.
Key exclusion criteria (6 listed)
- -Clinical manifestations of anaphylactic shock after the ingestion of cow's milk.
- -Non-IgE-mediated or non-immunological adverse reactions to cow's milk.
- -Malignant or immunopathological diseases and/or severe primary or secondary immune deficiencies.
- -Patients receiving immunosuppressor therapy.
- -Patients receiving beta-blockers (including topical formulations).
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 |
|---|---|---|
| Cow's milk | Other | – |
Primary outcome
Not reported in the source record.
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 13 Sep 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cow's milk in people with Food Hypersensitivity, run by General University Hospital of Valencia at 1 site in Spain.
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 8 inclusion and 6 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 13 Sep 2010. 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 Spain. 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.
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 13 Sep 2010.