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Master Allergen Child Nutrition. Reintroduction of Small Doses (MANOE)

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ClinicalTrials.gov Identifier: NCT02384707
Recruitment Status : Unknown
Verified November 2014 by University Hospital, Angers.
Recruitment status was:  Recruiting
First Posted : March 10, 2015
Last Update Posted : March 10, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Brief Summary:
Reintroduction of small doses of food in allergic children to lightening the elimination diet.

Condition or disease Intervention/treatment Phase
Food Allergies Other: allegic food Other: Placebo Not Applicable

Detailed Description:

In four groups of allergic children (peanuts, wheat , milk and egg), a reintroduction of 4 small increasing doses of allergen is carried out progressively double-blind placebo- cons , randomized, during a hospitalization.

The procedure for reintroduction of small doses (MPD) is stopped at the appearance of intolerance (in taking a dose of allergen or placebo) defined by the onset of allergic symptoms or objective severe abdominal pain within 45 minutes of taking.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Reintroduction of Small Doses of Food in Allergic Children to Lightening the Elimination Diet.
Study Start Date : May 2011
Actual Primary Completion Date : June 2011
Estimated Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: allergic food

Reintroduction procedure for small doses :

  • Administration of the first dose the first dose must be allergic food or placebo
  • Clinical monitoring for 45 minutes
  • Administration of the second dose
Other: allegic food

Reintroduction procedure for small doses :

  • Administration of the first dose
  • Clinical monitoring for 45 minutes
  • Administration of the second dose

Other: Placebo



Primary Outcome Measures :
  1. Tolerance for each ingested dose is assessed by a clinical score [ Time Frame: 45 minutes ]
    Tolerance is defined by the absence of allergy symptoms within 45 minutes of ingestion of the allergen dose in the absence of intolerance to previous placebo



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Ages Eligible for Study:   9 Months to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Allergic children 1 and 16 years for peanut, egg and wheat. So, for milk between 9 months and 16 years.
  • Accurate diagnostic
  • Allergic react rapidly and acute

Exclusion Criteria:

  • severe disease

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): NCT02384707


Contacts
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Contact: Martine Drouet madrouet@chu-angers.fr

Locations
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France
Denise Jolivot Recruiting
Angers, Pays de Loire, France, 49000
Contact: MARTINE DROUET, PH    33241354541    madrouet@chu-angers.fr   
Sponsors and Collaborators
University Hospital, Angers
Investigators
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Principal Investigator: Martine Drouet University Hospital, Angers

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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT02384707     History of Changes
Other Study ID Numbers: 2010-A00448-31
First Posted: March 10, 2015    Key Record Dates
Last Update Posted: March 10, 2015
Last Verified: November 2014
Additional relevant MeSH terms:
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Food Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases