Food AllergiesMANOENCT02384707
Master Allergen Child Nutrition. Reintroduction of Small Doses
A study testing allegic food in people with Food Allergies, run by University Hospital, Angers at 1 site in France.
Trial summary
Reintroduction of small doses of food in allergic children to lightening the elimination diet. Read more about this study
- Who is it for?
- Ages 9 months to 16 years
- Conditions the study is for
- Food Allergies
- What is being tested?
- allegic food
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- May 2011to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 months to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- severe disease
Trial locations and contacts
1 site in 1 country.
Martine Drouet contact
France1 site, 1 recruiting
- Recruiting
Denise Jolivot
Angers, Pays de Loire, 49000
MARTINE DROUET, PH, 33241354541, madrouet@chu-angers.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Food Allergies
- Being tested
- allegic food, Placebo
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allegic foodOther
Reintroduction procedure for small doses :
- Administration of the first dose
- Clinical monitoring for 45 minutes
- Administration of the second dose
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: allegic food; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study startMay 2011
- Primary completionJun 2011
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AllergiesStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Martine Drouet, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02384707
- Sponsor's protocol ID
- 2010-A00448-31
- Acronym
- MANOE
- Status last verified
- Nov 2014
- First submitted
- 24 Nov 2014
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reintroduction of Small Doses of Food in Allergic Children to Lightening the Elimination Diet.
- ClinicalTrials.gov ID
- NCT02384707
- Acronym / sponsor ID
- MANOE / 2010-A00448-31
- Conditions
- Food Allergies
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- May 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 10 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Reintroduction of small doses of food in allergic children to lightening the elimination diet.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| allergic food | Experimental | Other: allegic food, Other: PlaceboReintroduction 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 |
Who may qualify
- Ages
- 9 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- severe disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| allegic foodReintroduction procedure for small doses : * Administration of the first dose * Clinical monitoring for 45 minutes * Administration of the second dose | Other | allergic food |
| Placebo | Other | allergic food |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martine Drouet contact
Martine Drouet principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing allegic food in people with Food Allergies, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martine Drouet (madrouet@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerance for each ingested dose is assessed by a clinical score (time frame: 45 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2015.