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

NCT01641731 | Completed

• 1 other identifier: SOTI_CMA_HULP
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Cow's Milk Protein Sensitivity

Keywords

cow's milk protein allergy; oral tolerance induction

Outcome Measures

Primary Outcomes (1)

• Tolerance to cow's milk

  After administration of 250ml of milk, the patient is evaluated to determined if the milk is tolerated or not.

  12 months

Secondary Outcomes (1)

• Adverse events

  12 months

Study Arms (2)

Cow's milk

ACTIVE COMPARATOR

Other: Cow's milk

Control group

NO INTERVENTION

Interventions

Cow's milk OTHER

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.

Cow's milk

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age younger than 4 y.o.
• Specific IgE higher than 50 kU/L

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead

Study Sites (1)

Servicio de Alergia Infantil, Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Related Publications (6)

• Longo G, Barbi E, Berti I, Meneghetti R, Pittalis A, Ronfani L, Ventura A. Specific oral tolerance induction in children with very severe cow's milk-induced reactions. J Allergy Clin Immunol. 2008 Feb;121(2):343-7. doi: 10.1016/j.jaci.2007.10.029. Epub 2007 Dec 26.

  PMID: 18158176 BACKGROUND

• Zapatero L, Alonso E, Fuentes V, Martinez MI. Oral desensitization in children with cow's milk allergy. J Investig Allergol Clin Immunol. 2008;18(5):389-96.

  PMID: 18973104 BACKGROUND

• Caminiti L, Passalacqua G, Barberi S, Vita D, Barberio G, De Luca R, Pajno GB. A new protocol for specific oral tolerance induction in children with IgE-mediated cow's milk allergy. Allergy Asthma Proc. 2009 Jul-Aug;30(4):443-8. doi: 10.2500/aap.2009.30.3221. Epub 2009 Mar 13.

  PMID: 19288980 BACKGROUND

• Staden U, Rolinck-Werninghaus C, Brewe F, Wahn U, Niggemann B, Beyer K. Specific oral tolerance induction in food allergy in children: efficacy and clinical patterns of reaction. Allergy. 2007 Nov;62(11):1261-9. doi: 10.1111/j.1398-9995.2007.01501.x.

  PMID: 17919140 BACKGROUND

• Skripak JM, Nash SD, Rowley H, Brereton NH, Oh S, Hamilton RG, Matsui EC, Burks AW, Wood RA. A randomized, double-blind, placebo-controlled study of milk oral immunotherapy for cow's milk allergy. J Allergy Clin Immunol. 2008 Dec;122(6):1154-60. doi: 10.1016/j.jaci.2008.09.030. Epub 2008 Oct 25.

  PMID: 18951617 BACKGROUND

• Garcia-Ara C, Pedrosa M, Belver MT, Martin-Munoz MF, Quirce S, Boyano-Martinez T. Efficacy and safety of oral desensitization in children with cow's milk allergy according to their serum specific IgE level. Ann Allergy Asthma Immunol. 2013 Apr;110(4):290-4. doi: 10.1016/j.anai.2013.01.013. Epub 2013 Feb 14.

  PMID: 23535095 DERIVED

MeSH Terms

Conditions

Milk Hypersensitivity

Interventions

Milk

Condition Hierarchy (Ancestors)

Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Carmen García-Ara, MD, PhD

  Instituto de Investigación Sanitaria Hospital Universitario La Paz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2012
• First Posted: July 17, 2012
• Study Start: March 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: September 1, 2011
• Last Updated: July 17, 2012

Record last verified: 2012-07

Locations

ES (1)