Specific Oral Tolerance Induction in Children Allergic to Cow's Milk Proteins
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|ClinicalTrials.gov Identifier: NCT01641731|
Recruitment Status : Completed
First Posted : July 17, 2012
Last Update Posted : July 17, 2012
Induction of oral tolerance in children allergic to cow's milk proteins is not risk-free. The analysis of factors that may influence the outcome is of utmost importance.
The aim of the study is to analyse the efficacy and safety of the induction phase of oral tolerance induction according to specific IgE level, as well as adverse events during the maintenance phase.
Patients allergic to cow's milk are to be included in an oral tolerance induction protocol. Patients will be grouped according to specific IgE levels in serum (ImmunoCAP) into group I (sIgE<3.5 kU/L), II (sIgE 3.5-17 kU/L) and III (>17-50kU/L). Allergic children with similar characteristics will included as a control group. Visits are established at 1, 6 and 12 months after the induction phase. Serum specific IgE levels to cow's milk and its proteins will be determined at inclusion, and at 6 and 12 months visits after the induction phase.
|Condition or disease||Intervention/treatment||Phase|
|Cow's Milk Protein Sensitivity||Other: Cow's milk||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of Specific Oral Tolerance Induction in Children Allergic to Cow's Milk Proteins According to Their Serum Specific IgE Level|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||September 2011|
|Active Comparator: Cow's milk||
Other: Cow's milk
Group I: Increase 2 mL until 10 mL, 10 mL until 50 mL, 20 mL until 100 mL and 50 mL until 200 mL was reached.
Groups II and III: Doubling dose until 1 mL, increase 2 mL until 20 mL, 5 mL until 50 mL, 10 mL until 100 mL and 20 mL until 200 mL was reached.
|No Intervention: Control group|
- Tolerance to cow's milk [ Time Frame: 12 months ]After administration of 250ml of milk, the patient is evaluated to determined if the milk is tolerated or not.
- Adverse events [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01641731
|Servicio de Alergia Infantil, Hospital Universitario La Paz|
|Madrid, Spain, 28046|
|Principal Investigator:||Carmen García-Ara, MD, PhD||Instituto de Investigación Sanitaria Hospital Universitario La Paz|