Early Introduction and Sustained Ingestion (EISI) Using Two Educational Opportunities in Infants

May 4, 2026 updated by: R. Sharon Chinthrajah, Stanford University

Early Introduction and Sustained Ingestion (EISI) Using Two Educational Opportunities - A Pilot Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This 6 month study will randomly assign caretaker/child dyads into two groups; 50% will be assigned to the intervention group, the other 50% to the standard-of-care group. Using the foods of each families home and culture, participants in the standard-of-care group will be instructed through 3 packets metered one month apart of scientifically supported written, audio and video materials that are widely available to the general public. The intervention group will receive the same educational materials at the same time points as the standard-of-care group. The intervention group will additionally have in-person or live-stream video opportunities instructing further about the same materials and ask questions of the research team. The intervention group will additionally have one and up to two opportunities to feed their infant in the clinical research unit one of the top 9 known US allergenic foods (Top 9) with the feeding staffed with emergency response personnel and supportive clinical care. Both groups will complete the same quiz following each educational set of materials to evaluate the helpfulness and understanding of each. Both groups will record the intake of the Top 9 for the first 3 months. Both groups will record the intake of the Top 9, fruit/vegetable, whole grains, legumes, seeds and ultra processed food intake for the second 3 months of the study. Both groups will undergo a blood draw on the infant at the first and last visits. Both groups will complete a pre and post study questionnaire.

The standard-of-care group will be offered the opportunity to return to the clinic to feed a Top 9 food when their enrollment is fully completed.

Study Type

Interventional

Enrollment (Estimated)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 T9 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 Top 9 known allergenic foods
  • Infants participating in another study looking at diet, oral immunotherapy or the use of a biological agent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of Care
The participants will be provided with three sets of educational materials to learn about early introduction of food allergens.
Experimental: Enhanced Educational Opportunities
The participants will be provided with three sets of educational materials to learn about early introduction of food allergens, as well as 3 in-person monthly teaching sessions (up to 3 months), lasting 30 minutes to enhance the information and allow for questions. This arm will also have one to two in-clinic feedings of any of the top 9 most allergenic foods. The oral feeding portion will add an additional 1 to 2 hours at the one of the 3 visits.
Behavioral: Educational Sessions and Opportunities on Early Introduction and Sustained Ingestion
The participant will attend three in person sessions on the basics of food allergy, food allergy reactions, feeding safety and readiness, fiber, ultra processed foods, diet diversity, and advancing food textures in the infant diet. The educational sessions will last 20 - 30 minutes every month for three months.
Behavioral: In person feeding session
Participants will attend an in-person feeding of a known top 9 food allergen (hen's egg, cow's milk, peanut, tree nuts, soy, wheat, fin fish, shellfish, and sesame) to the infant at least one time, and up to two times. The clinic feeding will last 1 - 2 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the infant age at which allergenic foods were introduced
Time Frame: Baseline up to six months.
The average age of introduction of allergenic foods will be calculated and compared between groups.
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, month 5 and month 6.
The participants will self report how many times they took a particular allergenic food each month. This outcome will be compared between the two groups.
At the start of intervention and month 1, month 2, month 3, month 4, month 5 and month 6.
Compare the quantity of allergenic foods consumed.
Time Frame: At the start of intervention and month 4, month 5 and month 6.

The participants will measure the amount of allergenic foods consumed daily as either: a taste, ≤ 1 teaspoon,

1 - 2 teaspoons or ≥ 3 tablespoons. The total amount of food consumed in a month will be compared between the two groups.
At the start of intervention and month 4, month 5 and month 6.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Sharon Chinthrajah, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

December 15, 2025

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 81307

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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