Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1U01AI125290 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| Massachusetts General Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peanut in diet | Other |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of infants with peanut allergy at baseline | Percentage of infants who fail the peanut challenge at the baseline visit | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Compare results of peanut skin prick test to peanut challenge outcomes among the high risk infants | Results of peanut skin prick tests compared to peanut challenge among the high risk infants | baseline |
| Compare results of anti-peanut IgE testing to peanut challenge outcomes among the high risk infants |
Not provided
Inclusion Criteria:
Infants age 4-11 months
Have at least one of the following criteria:
Exclusion Criteria:
Not provided
Not provided
Infants age 4 monhts to 11 months
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Corinne Keet, MD | Johns Hopkins University | Principal Investigator |
| Robert Wood, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States | ||
| Massachusetts General Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D021183 | Peanut Hypersensitivity |
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D000074924 | Nut and Peanut Hypersensitivity |
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
Not provided
Not provided
| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Bloods, skin swabs, skin tape strips
Results of anti-peanut IgE testing compared to peanut challenge among the high risk infants |
| baseline |
| Compare results of anti-Ara h2 IgE testing to peanut challenge outcomes among the high risk infants | Results of anti-Ara h2 IgE testing compared to peanut challenge among the high risk infants | baseline |
| Percent of infants who develop peanut allergy by age 30 months | Percent of infants at risk who develop peanut allergy during the study window (30 months) | 30 months |
| Percent of infants with a skin prick test of 3 mm or more at baseline who develop peanut allergy | Percent of infants with a positive skin prick test who develop peanut allergy during the study window (30 months) | 30 months |
| Peanut levels in bedroom dust as measured by home dust collection | Peanut levels will be tested by Elisa in bed dust collected by patients using a DUSTREAM(R) vacuum adaptor. | 18 months |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| D007154 | Immune System Diseases |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |