Investigating the impact of breast milk on food allergies in infants
Evaluation of Human Breast Milk and Its Role in Early Food Allergen Sensitization in Infants
This study is testing if breast milk can pass on food allergens like milk, egg, and peanut to babies and whether introducing these foods early can help prevent food allergies in infants.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 4 Months to 24 Months |
| Sex | All |
| Sponsor | The University of Texas Medical Branch, Galveston Academic / other |
| Locations | 1 site (League City, Texas) |
| Trial ID | NCT06765213 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the transmission of food allergens, specifically milk, egg, and peanut, through breast milk to breastfeeding infants. Pregnant or postpartum women with a history of atopic diseases will provide breast milk samples for allergen testing. Infants will undergo skin prick and blood testing for sensitization to these allergens before solid food introduction. The study will also assess whether early introduction of these foods can prevent the development of food allergies in infants.
Who should consider this trial
Good fit: Ideal candidates include pregnant or postpartum women with a personal history of atopic diseases who plan to exclusively breastfeed.
Not a fit: Patients who do not have a history of atopic disease or those who are exclusively formula feeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new guidelines for breastfeeding mothers to help reduce the risk of food allergies in their infants.
How similar studies have performed: While there have been studies on food allergies and breastfeeding, this specific approach focusing on allergen transmission through breast milk is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Pregnant or post-partum females who plan to exclusively breastfeed and their infants who have completed at least 37 weeks of gestation 1. These are vulnerable populations 2. Our study involves breastmilk analysis, which we need postpartum mothers to supply. 3. (Parent) Testing will be done solely on breastmilk samples, with only potential dietary intervention done to the parent postpartum depending on the outcomes of the infant and breastmilk. 4. (Infant) In order to determine if allergens in breastmilk play a role in food allergen sensitization, we need to test the infants prior to the introduction of solid foods. 2. Personal history of atopic disease such as allergic rhinitis/conjunctivitis, asthma, food allergies, and atopic dermatitis 3. Maternal diet must include hen's egg, cow's milk, and wheat products. Exclusion Criteria: 1. No maternal history of atopic disease 2. Exclusive formula feeding 3. Maternal diet devoid of hen's egg, cow's milk, or wheat, for example, vegan diets and persons with gluten sensitivity.
Where this trial is running
League City, Texas
- Pediatric Sub Specialty Clinic at Bay Colony — League City, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Cleavon Covington, MD
- Email: clcoving@utmb.edu
- Phone: 409-772-0433
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.