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Specific Oral Tolerance Induction in Children Allergic to Cow's Milk Proteins

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01641731
Recruitment Status : Completed
First Posted : July 17, 2012
Last Update Posted : July 17, 2012
Sponsor:
Information provided by (Responsible Party):
Instituto de Investigación Hospital Universitario La Paz

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Casein

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-Patients diagnosed with cow's milk allergy meeting the following 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 )

  • Age 4 years old or older
  • Specific IgE (measured by ImmunoCAP) lower than 50 KU/L for cow's milk or its proteins
  • Positive oral food challenge with a dose higher than 2 mL
  • Written informed consent signed by parents or legal representatives

Exclusion Criteria:

  • Age younger than 4 y.o.
  • Specific IgE higher than 50 kU/L
  • Patients in whom oral food challenges is contraindicated, because of having a positive accidental reaction with moderate or severe symptoms in the previous 12 months prior to the inclusion.

Information from the National Library of Medicine

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


Locations
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Spain
Servicio de Alergia Infantil, Hospital Universitario La Paz
Madrid, Spain, 28046
Sponsors and Collaborators
Instituto de Investigación Hospital Universitario La Paz
Investigators
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Principal Investigator: Carmen García-Ara, MD, PhD Instituto de Investigación Sanitaria Hospital Universitario La Paz

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT01641731    
Other Study ID Numbers: SOTI_CMA_HULP
First Posted: July 17, 2012    Key Record Dates
Last Update Posted: July 17, 2012
Last Verified: July 2012
Keywords provided by Instituto de Investigación Hospital Universitario La Paz:
cow's milk protein allergy
oral tolerance induction
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases
Caseins
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action