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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01AI173032 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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Peanut allergy is the most common cause of fatal and near-fatal food-allergic reactions and egg allergy is among the two most common causes of food-induced anaphylaxis. The proposed research will explore the development of sensitization to these food(s) in infants based on maternal consumption or avoidance during pregnancy and breastfeeding.
The goals of this study include defining the role of egg and peanut consumption or avoidance during pregnancy and via human milk in food sensitization and identifying the underlying biological mechanisms leading to sensitization or tolerance. The study population will include 500 mother/infant dyads who plan to exclusively feed breastmilk to healthy infants. We expect approximately 25% will be recruited locally and the rest from across the United States. This is a national, parallel, two arm, one-to-one allocation, single blinded, randomized controlled trial. Each arm of the study defines maternal diet from 27 weeks gestation through their baby's fourth month with some consuming peanut and egg and some avoiding these foods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 Consumption | Active Comparator | Subjects must consume peanuts and peanut products and egg and egg products. |
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| Arm 2 Avoidance | Active Comparator | Subjects must avoid eating peanuts and peanut products and egg and egg products. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Consumption | Behavioral | Subjects consume peanut and egg from 27 weeks of pregnancy through the first 4 months feeding breastmilk to their infant. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Egg or peanut sensitization | Determine the proportion of high-risk infants who have developed egg or peanut sensitization at four months (prior to introduction of these foods to the infant). | four months |
| Measure | Description | Time Frame |
|---|---|---|
| Peanut and egg specific IgG and IgG4 | Levels of infant peanut and egg specific IgG and IgG4 | four months |
| Antibodies in maternal blood | Quantify egg- and PN-specific IgG and IgG4 antibody concentrations in maternal blood measured during pregnancy and at four months. |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory: Peanut sensitization | The proportion of high-risk infants who have developed peanut sensitization | four months |
| Exploratory: Egg sensitization | Proportion of infants who develop egg sensitization. |
Inclusion Criteria:
• o Subject must be able to understand and provide informed consent.
English-speaking adults, 18 years or older. (Spanish speaking adults may be included after consent document is translated and Spanish speaking study representatives are available to conduct and answer questions during informed consent process and for study follow up.)
Maternal consent must be provided for infants.
Pregnant women from the time pregnancy is confirmed until 27 weeks of gestation.
Self-reported at time of enrollment:
Intend to give their infant their own breast milk for more than 3 months.
Can confidently say they have eaten PN and egg and have tolerated consumption with no food allergy reactions.
Willing to be randomized to consumption or avoidance diet.
Uncomplicated pregnancy (no gestational diabetes, no preeclampsia, no hyperemesis gravidarum), self-reported at time of enrollment.
Exclusion Criteria:
To understand the mechanisms whereby maternal diet either positively or negatively affects the development of their infant from the womb through the first few months of life, it is necessary to recruit healthy pregnant women.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Allison W Leadley, MPH | Contact | 585-275-4640 | allison_leadley@urmc.rochester.edu | |
| Leanna Twohig, MS | Contact | 585-275-4640 | Leanna_Twohig@urmc.rochester.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Recruiting | Rochester | New York | 14642 | United States |
Per NIH policy
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| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| D000074924 | Nut and Peanut Hypersensitivity |
| D021181 | Egg Hypersensitivity |
| D021183 | Peanut Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
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| ID | Term |
|---|---|
| D004467 | Economics |
| C000625000 | SAV4 protein, Arabidopsis |
| ID | Term |
|---|---|
| D004472 | Health Care Economics and Organizations |
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National, parallel, two arm (one-to-one allocation), single blinded, randomized controlled trial.
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Due to the nature of the intervention, the subjects must know which arm they are assigned to, however, biostatistician and investigators will be blinded to study assignment.
| Avoidance | Behavioral | Subjects avoid eating peanut and egg from 27 weeks of pregnancy through the first 4 months feeding breastmilk to their infant. |
|
| four months |
| Egg allergy | Questionnaire for parents to report any signs of egg allergy in their child. | 12 months |
| Egg and peanut specific IgE | Measure levels of infant egg- and peanut-specific IgE. | four months |
| four months |
| Exploratory: Symptoms | Questionnaire for parents to report symptoms of non-IgE mediated food allergy | four months |
| Exploratory: Peanut sensitization 12 months | Questionnaire for parents to report signs of peanut allergy | 12 months |
| Mechanistic: antigen level | Measure PN and egg antigen levels in house dust and human milk | four months |
| Mechanistic: IgG levels | Quantify PN- and egg-specific IgG antibody levels in maternal serum and human milk. | four months |
| Mechanistic: T cell | Phenotype infant T cell populations in cord blood and infant blood. | four months |