Master Allergen Child Nutrition. Reintroduction of Small Doses

Food Allergies Clinical Trial

— MANOE  

Official title:

Reintroduction of Small Doses of Food in Allergic Children to Lightening the Elimination Diet.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02384707
• Other study ID #: 2010-A00448-31
• Status: Recruiting
• Phase: N/A
• First received: November 24, 2014
• Last updated: March 9, 2015
• Start date: May 2011
• Est. completion date: December 2015

Study information

• Verified date: November 2014
• Source: University Hospital, Angers
• Contact: Martine Drouet
• Email: madrouet[@]chu-angers.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2015
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Months to 16 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Food Allergies
• Food Hypersensitivity

Intervention

Other:
• allegic food
Reintroduction procedure for small doses : Administration of the first dose Clinical monitoring for 45 minutes Administration of the second dose
• Placebo

Locations

Country	Name	City	State
France	Denise Jolivot	Angers	Pays de Loire

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerance for each ingested dose is assessed by a clinical score	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	45 minutes	Yes