Early Peanut Introduction: Translation to Clinical Practice
| Status: | Recruiting |
|---|---|
| Conditions: | Allergy, Allergy, Neurology |
| Therapuetic Areas: | Neurology, Otolaryngology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 9/21/2018 |
| Start Date: | December 2016 |
| End Date: | December 2021 |
| Contact: | Daria Szelag, CRNP |
| Email: | earlypeanutstudy@jhmi.edu |
| Phone: | 410-502-4198 |
The recent finding that early introduction of peanut can prevent ~70-90% of peanut allergy is
a major step towards prevention of food allergy. However, because that finding was from a
clinical trial in a very select population, there are several major questions that must be
answered in order to implement these findings into clinical practice without causing more
harm than good. These questions include who, if anyone, should be screened prior to early
introduction for peanut allergy, how this screening should be done, and what quantity of
peanut ingestion is needed to prevent peanut allergy. The goal of this project is to answer
these critical questions so that the potential of these recent findings can be realized. To
that end, 400 infants at high-risk of peanut allergy will be enrolled. These infants will be
given a peanut skin prick test, peanut food challenge and have blood drawn for measurement of
peanut IgE, and then will be followed for assessment of peanut consumption and development of
peanut allergy until 3 years of age.
a major step towards prevention of food allergy. However, because that finding was from a
clinical trial in a very select population, there are several major questions that must be
answered in order to implement these findings into clinical practice without causing more
harm than good. These questions include who, if anyone, should be screened prior to early
introduction for peanut allergy, how this screening should be done, and what quantity of
peanut ingestion is needed to prevent peanut allergy. The goal of this project is to answer
these critical questions so that the potential of these recent findings can be realized. To
that end, 400 infants at high-risk of peanut allergy will be enrolled. These infants will be
given a peanut skin prick test, peanut food challenge and have blood drawn for measurement of
peanut IgE, and then will be followed for assessment of peanut consumption and development of
peanut allergy until 3 years of age.
400 infants aged 4-11 months from three high risk groups will be enrolled in a prospective
observational study. All subjects will have a baseline research clinic visit, where they will
be given a peanut skin prick test, peanut food challenge and have blood drawn for measurement
of peanut immunoglobulin E (IgE). Based on the baseline oral food challenge, the participants
will be advised to begin introducing peanut following the current practice guidelines.
Participants will then be followed until 30 months of age with two clinic visits and regular
monitoring of peanut consumption.
observational study. All subjects will have a baseline research clinic visit, where they will
be given a peanut skin prick test, peanut food challenge and have blood drawn for measurement
of peanut immunoglobulin E (IgE). Based on the baseline oral food challenge, the participants
will be advised to begin introducing peanut following the current practice guidelines.
Participants will then be followed until 30 months of age with two clinic visits and regular
monitoring of peanut consumption.
Inclusion Criteria:
- Infants age 4-11 months
- Have at least one of the following criteria:
1. physician diagnosis of milk, egg or other non-peanut food allergy,
2. at least moderate eczema as defined by a SCORAD score of at least 25 on present
or previous evaluation, OR a rash that required the application of topical creams
or ointments containing corticosteroids or calcineurin inhibitors and occurred on
at least 7 days on two separate occasions, or is described by the parent or
guardian as "a bad rash in joints or creases" or "a bad itchy, dry, oozing or
crusted rash".
3. a first degree relative (parents or siblings) with either a physician diagnosis
of IgE mediated peanut allergy OR reported history of symptoms consistent with
IgE mediated peanut allergy (onset of symptoms within 2 hours of exposure, AND
symptoms of urticaria, angioedema, wheezing, vomiting, or abdominal pain with
exposure, AND no subsequent exposure to peanut without symptoms).
Exclusion Criteria:
- History of feeding problems
- History of eosinophilic gastro-intestinal disease
- Significant medical history (aside from eczema, food allergy or history of wheeze)
- History of peanut reactions or tolerance prior to baseline screening
We found this trial at
2
sites
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Wayne Shreffler, MD
Phone: 617-724-2081
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