Recruiting

Educational Support

Sponsor:

Stanford University

Code:

NCT07321522

Conditions

Food Allergy

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Interventions

Education and Opportunities on Early Introduction

Clinician Supervised Feeding of Known Allergenic Food

Study Details

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.

Conditions

Food Allergy

Study ID

NCT07321522

Start date

Jun 30, 2026

Status verified date

Jun, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

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

Study Design

Enrollment

92 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Standard of Care

The participants in the standard-of-care (SOC) group will be provided with three sets of nonsynchronous educational materials or modules to learn about early introduction of known food allergens and infant nutrition. A quiz will follow each educational module. Participants have the option to come to the research clinic to introduce known allergenic foods under clinician supervision. If none of the 9 most common known allergenic foods in the US (peanut, tree nut, hen's egg, cow's milk, soy, sesame, finned fish, shell fish, wheat) have been fed to the infant by the end of 3 months study enrollment the participant will be required to return to the research clinic for an introductory feeding of a known allergenic food of their choice under clinical supervision. The oral feeding will last approximately 1 hour.

experimental: Enhanced Educational Opportunities

The participants in the experimental group will be provided with the same three sets of educational materials or modules as the SOC group to learn about early introduction of food allergens and infant nutrition. Experimental participants will also attend 3 in-person or live video conferencing education sessions paired with each of the 3 educational modules. The educational classes last 30 minutes and are meant to enhance the information and allow opportunities for questions. The same quiz as the SOC group will follow each educational module. This arm will be required to return to the research clinic for at least one introductory feeding of a known allergenic food (peanut, tree nut, egg, milk, soy, sesame, finned fish, shell fish, wheat) during the first three months of the study under clinician supervision. The oral feeding will last approximately 1 hour.

Interventions

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.

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 measure

  • Compare the infant age at which allergenic foods were introduced [ Time Frame: Baseline up to six months. ]
  • 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. ]

Central Contacts and Locations

Locations

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

More Information

Sponsor

Stanford University

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-06-26.