NCT02384707

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 10, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 10, 2015

Status Verified

November 1, 2014

Enrollment Period

1 month

First QC Date

November 24, 2014

Last Update Submit

March 9, 2015

Conditions

Food Allergies

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

allergic food

EXPERIMENTAL

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 foodOther: Placebo

Interventions

allegic foodOTHER

Reintroduction procedure for small doses : * Administration of the first dose * Clinical monitoring for 45 minutes * Administration of the second dose

allergic food
PlaceboOTHER
allergic food

Eligibility Criteria

Age9 Months - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • severe disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Denise Jolivot

Angers, Pays de Loire, 49000, France

RECRUITING

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Martine Drouet

    University Hospital, Angers

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Martine Drouet

CONTACT

madrouet@chu-angers.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2014

First Posted

March 10, 2015

Study Start

May 1, 2011

Primary Completion

June 1, 2011

Study Completion

December 1, 2015

Last Updated

March 10, 2015

Record last verified: 2014-11

Locations

FR(1)