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

March 9, 2015 updated by: University Hospital, Angers

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Pays de Loire
      • Angers, Pays de Loire, France, 49000
        • Recruiting
        • Denise Jolivot
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 months to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: Placebo
Other: allegic food

Reintroduction procedure for small doses :

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
45 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: Martine Drouet, University Hospital, Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

June 1, 2011

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

November 24, 2014

First Submitted That Met QC Criteria

March 9, 2015

First Posted (Estimate)

March 10, 2015

Study Record Updates

Last Update Posted (Estimate)

March 10, 2015

Last Update Submitted That Met QC Criteria

March 9, 2015

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-A00448-31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Food Allergies

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe