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Completed

NCT Number: NCT01361347

Safety of Oral Immunotherapy for Cow's Milk Allergy in School-aged Children

The purpose of this study is to study the number of Participants with Adverse Events as a Measure of Safety and Tolerability.

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Key information

Conditions

Milk Allergy Anaphylaxis Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Milk Hypersensitivity

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tampere University Hospital, Allergy Centre

Tampere, FIN-33521, Finland

About this study

Eligibility criteria:

Age 6 - 16 yrs

  • IgE-mediated milk allergy
  • and milk provocation within 3 months prior to or an documented accidental milk contact with clear immediate symptoms

Outcome measures:

  • number of patients with successful desensitization (195 - 200 ml milk per day)
  • number of patients with adverse events

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • IgE-mediated milk allergy
  • An immediately positive challenge test result to milk prior to inclusion

Exclusion criteria

  • Not willing to participate

Treatment and study plan

Milk

Dietary Supplement

milk for milk allergic children (1:25 dilution, whole milk)

Other names: milk allergy, desensitization

Primary outcomes

  1. Number of participants with adverse events as a measure of safety and tolerability

    Time frame: 12 months

Secondary outcomes

  1. Number of participants drinking 2 dl/day of milk (success in desensitization)

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Registry information

Official study title

Phase 4 Study: Milk Oral Immunotherapy for Cow's Milk Allergy in School-aged Children

Important dates

Study start
2008
Primary completion
2016
Study completion
2016
First posted
May 26, 2011
Registry last updated
Jan 4, 2017

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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