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

June 23, 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

Recruiting

Conditions

Intervention / Treatment

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.

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

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 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 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 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.
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.

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.
Compare the number of known allergenic foods introduced and sustained in the diet for 3 months in each study arm.
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.
Characterize diet diversity between the standard of care arm and the experimental arm.
At the start of intervention and month 1, month 2, month 3, month 4, 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 30, 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)

June 26, 2026

Last Update Submitted That Met QC Criteria

June 23, 2026

Last Verified

June 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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