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Completed

NCT Number: NCT01199484

Specific Oral Tolerance Induction to 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.

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Key information

Conditions

Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Milk Hypersensitivity

Age range

24 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Allergy Unit. University General Hospital

Valencia, 46014, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • -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.

Exclusion criteria

  • -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

Treatment and study plan

Cow's milk

Other

Sponsors and collaborators

Lead sponsor

General University Hospital of Valencia

Other

Registry information

Official study title

Specific Oral Tolerance Induction as an Useful Treatment in Two-year-old Children With Cow's Milk Allergy.

Important dates

First posted
Sep 13, 2010
Registry last updated
Sep 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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