NCT07321522 · Stanford University
Early Introduction and Sustained Ingestion (EISI) Using Two Educational Opportunities in Infants
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Education 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.
BEHAVIORAL
Clinician 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.
Primary outcome measures
Compare the infant age at which allergenic foods were introduced
Time frame: 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.
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Stanford, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 26, 2026 · Source of record for eligibility and locations