Food Allergy
Conditions
Brief summary
The objective of the study is to see whether early feeding of potentially allergic foods can be increased with educational materials alone or with educational materials and additional in-person support opportunities. This study will help guide what types of support pediatricians and allergists give to new parents.
Detailed description
This 6 month feasibility pilot study will randomly assign caretaker/child dyads into two groups stratified by age; 50% will be assigned to the intervention group, the other 50% to the standard-of-care group (SOC). Using the foods of each families home and culture, participants in the standard-of-care group will be instructed through 3 educational packets in early introduction and infant nutrition metered one month apart. The content includes scientifically supported written, audio and video materials that are widely available to the general public. The SOC group has the option to come to the clinical research unit and introduce known allergenic foods under clinician supervision. The intervention group will receive the same 3 educational materials at the same time points as the SOC group. Both groups will complete the same quiz following each educational set of materials to evaluate the helpfulness and understanding of each educational module. The intervention group will additionally have in-person or live-stream opportunities instructing further about the same materials and provide the opportunity for participants to ask questions of the research team. The intervention group will be required to return to the research unit for at least one feeding introduction of a known allergenic food during the first 3 months of the study with clinicians present to supervise the feeding. The SOC group has the option to return to the clinic for at least one feeding introduction of a known allergenic food with clinical supervision. If a SOC participant had not consumed any known allergenic foods by the end of 3 months study enrollment, they will be required to come to the research clinic for a feeding introduction of a known allergenic food of their choice. Both groups will record the intake of known allergenic foods for the first 3 months. The second half of the study, intake of allergenic foods, diet diversity, fiber and fermented foods will be assessed by a validated food frequency questionnaire. Both infant groups will undergo a blood draw, skin tape strips, transepidermal water loss measurements and stool collections on the first and last visits. Mothers who are lactating will provide a nipple swab and have the option to collect a breast milk sample. Both groups will complete a pre and post study anxiety surveys and early introduction knowledge questionnaires.
Interventions
BEHAVIORALEducation and Opportunities on Early Introduction
The participant will receive and review three educational modules on the basics of food allergy, food allergy reactions, food allergen introduction, feeding safety and readiness, fiber, fermented food, ultra processed foods, diet diversity, and advancing food textures in the infant diet. The educational sessions will take approximately one hour to review every month for three months.
BEHAVIORALClinician Supervised Feeding of Known Allergenic Food
Clinician supervised feeding introduction of a known allergenic food (hen's egg, cow's milk, peanut, tree nuts, soy, wheat, fin fish, shellfish, and sesame) to the infant at least one time during the 6 month enrollment. The feeding is required for the intervention group and optional for the standard-of-care (SOC) group. Participants in the SOC group who do not introduce any known allergenic foods at home into the infant's diet by the end of 3 months enrollment will be required to return to the clinic for a clinician supervised feeding of a known allergenic food of their choice. The clinic feeding will last approximately 1 hour.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Months to 11 Months
Healthy volunteers
Yes
Inclusion criteria
for both Infant and Caregiver/Parent Participants * Born term (37 weeks - 41 weeks gestation) * Infants with or without a family history of allergic disease * Infants with or without mild to moderate eczema * Infants who have not yet started consuming known allergenic foods (excluding cow's milk or soy if it is in their infant formula) * Parent or caregiver ≥ 18 years of age * Agree to infant blood draw (two) * Agree to participate in the 6 month research study
Exclusion criteria
* Infants with a physician confirmed food allergy * Infants who do not eat fully by an oral route such as tube-fed or tube-supplemented babies * Infants with developmental delay * Infants with severe eczema * Infants who are already consuming known allergenic foods * Infants participating in another study looking at diet, oral immunotherapy or the use of a biological agent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare the infant age at which allergenic foods were introduced | Baseline up to six months. | Compare the number of known allergenic foods introduced and sustained in the diet for 3 months in each study arm. |
| Compare the allergenic food intake frequency. | At the start of intervention and month 1, month 2, month 3, month 4, and month 6. | Characterize diet diversity between the standard of care arm and the experimental arm. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSharon Chinthrajah, MD
Stanford University
Outcome results
None listed