Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
No participants enrolled
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Texas Allergy, Asthma, and Immunology Society | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
The goal of this prospective cohort pilot study is to learn about food allergens being passed on in breast milk to breast feeding infants.
The main question[s] it aims to answer are:
Participants will
Recruitment of subjects will be open enrollment pregnant or post-partum women with a personal history of atopic disease such as allergic rhinitis/conjunctivitis, asthma, atopic dermatitis (eczema), and/or food allergy who are exclusively breastfeeding.
Mothers will provide a breastmilk sample(s) for testing of allergens to milk, egg, and wheat. Prior to the introduction of solid foods, infants will need to be tested for sensitization to milk, egg, and wheat via skin prick testing and blood allergy testing.
Infants that are negative for sensitization will undergo introduction of these foods per standard practice. Infants that are positive for sensitization will undergo an office food challenge for those foods that they are sensitized to. A positive food challenge is diagnostic for a food allergy and they will be managed according to standard practice. A negative food challenge means that they are not allergic, and they will undergo early introduction protocols and monitored to continued tolerance.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breastmilk positive/Infant sensitized | This group is for infants whose mother's breastmilk is found to be positive for allergens to either cow milk, egg, and/or wheat and who are found to be sensitized to one or more of these allergens. |
| |
| Breastmilk positive/Infant not sensitized | This group is for infants whose mother's breastmilk is found to be positive for allergens to either cow milk, egg, and/or wheat and who are found to be not sensitized to the three allergens. |
| |
| Breastmilk negative/Infant sensitized | This group is for infants whose mother's breastmilk is found to be negative for allergens to either cow milk, egg, and/or wheat and who are found to be sensitized to one or more of these allergens. |
| |
| Breastmilk negative/Infant not sensitized | This group is for infants whose mother's breastmilk is found to be negative for allergens to either cow milk, egg, and/or wheat and who are found to be not sensitized to the three allergens. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open Ended Oral Food Challenge | Diagnostic Test | Allergens determined to be sensitized will be brought in for an oral challenge to that food. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the detection of allergens in human breast milk | A mass spectrometry will be used to detect the allergens. Mass spectrometry is a technique used in the University of Texas Medical Branch (UTMB) laboratory to detect allergens. | Baseline (4 months of age) |
| To assess breast milk's role in sensitization to allergens | The infant will be skin prick tested for allergens to milk, eggs, and wheat at 4 months, which is the baseline. | Baseline (4 months of age) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of non-sensitized participants | The infants that are non-sensitized will begin consuming milk, eggs, and wheat, and each well child check visit. | Baseline (4 months of age), 12 months of age, 24 months of age |
Not provided
Inclusion Criteria:
Pregnant or post-partum females who plan to exclusively breastfeed and their infants who have completed at least 37 weeks of gestation
Personal history of atopic disease such as allergic rhinitis/conjunctivitis, asthma, food allergies, and atopic dermatitis
Maternal diet must include hen's egg, cow's milk, and wheat products.
Exclusion Criteria:
Not provided
Not provided
Infants at 4 months of age up to 24 months of age.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| D061186 | Breast Milk Expression |
| D005512 | Food Hypersensitivity |
| D016269 | Milk Hypersensitivity |
| D021181 | Egg Hypersensitivity |
| D021182 | Wheat Hypersensitivity |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
Not provided
Not provided
Not provided
Not provided
Not provided
| Early Introduction | Other | Infants that are not sensitized will have the food introduced to their diet at regular intervals. |
|
| D007154 |
| Immune System Diseases |