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

NCT07321522 | Recruiting DMC

• 1 other identifier: 81307
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Compare the infant age at which allergenic foods were introduced

  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.

  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.

Study Arms (2)

Standard of Care

NO INTERVENTION

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.

Enhanced Educational Opportunities

EXPERIMENTAL

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; Behavioral: Clinician Supervised Feeding of Known Allergenic Food

Interventions

Education and Opportunities on Early Introduction BEHAVIORAL

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.

Enhanced Educational Opportunities

Clinician Supervised Feeding of Known Allergenic Food BEHAVIORAL

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.

Enhanced Educational Opportunities

Eligibility Criteria

• Age: 4 Months - 11 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

RECRUITING

Related Publications (12)

• Warren CM, Aktas ON, Manalo LJ, Bartell TR, Gupta RS. The epidemiology of multifood allergy in the United States: A population-based study. Ann Allergy Asthma Immunol. 2023 May;130(5):637-648.e5. doi: 10.1016/j.anai.2022.12.031. Epub 2022 Dec 31.

  PMID: 36596337 BACKGROUND

• Gupta R, Holdford D, Bilaver L, Dyer A, Holl JL, Meltzer D. The economic impact of childhood food allergy in the United States. JAMA Pediatr. 2013 Nov;167(11):1026-31. doi: 10.1001/jamapediatrics.2013.2376.

  PMID: 24042236 BACKGROUND

• Togias A, Cooper SF, Acebal ML, Assa'ad A, Baker JR Jr, Beck LA, Block J, Byrd-Bredbenner C, Chan ES, Eichenfield LF, Fleischer DM, Fuchs GJ 3rd, Furuta GT, Greenhawt MJ, Gupta RS, Habich M, Jones SM, Keaton K, Muraro A, Plaut M, Rosenwasser LJ, Rotrosen D, Sampson HA, Schneider LC, Sicherer SH, Sidbury R, Spergel J, Stukus DR, Venter C, Boyce JA. Addendum guidelines for the prevention of peanut allergy in the United States: Report of the National Institute of Allergy and Infectious Diseases-sponsored expert panel. J Allergy Clin Immunol. 2017 Jan;139(1):29-44. doi: 10.1016/j.jaci.2016.10.010.

  PMID: 28065278 BACKGROUND

• Du Toit G, Roberts G, Sayre PH, Bahnson HT, Radulovic S, Santos AF, Brough HA, Phippard D, Basting M, Feeney M, Turcanu V, Sever ML, Gomez Lorenzo M, Plaut M, Lack G; LEAP Study Team. Randomized trial of peanut consumption in infants at risk for peanut allergy. N Engl J Med. 2015 Feb 26;372(9):803-13. doi: 10.1056/NEJMoa1414850. Epub 2015 Feb 23.

  PMID: 25705822 BACKGROUND

• Perkin MR, Logan K, Marrs T, Radulovic S, Craven J, Flohr C, Lack G; EAT Study Team. Enquiring About Tolerance (EAT) study: Feasibility of an early allergenic food introduction regimen. J Allergy Clin Immunol. 2016 May;137(5):1477-1486.e8. doi: 10.1016/j.jaci.2015.12.1322. Epub 2016 Feb 17.

  PMID: 26896232 BACKGROUND

• Natsume O, Kabashima S, Nakazato J, Yamamoto-Hanada K, Narita M, Kondo M, Saito M, Kishino A, Takimoto T, Inoue E, Tang J, Kido H, Wong GW, Matsumoto K, Saito H, Ohya Y; PETIT Study Team. Two-step egg introduction for prevention of egg allergy in high-risk infants with eczema (PETIT): a randomised, double-blind, placebo-controlled trial. Lancet. 2017 Jan 21;389(10066):276-286. doi: 10.1016/S0140-6736(16)31418-0. Epub 2016 Dec 9.

  PMID: 27939035 BACKGROUND

• Venter C, Groetch M. Emerging concepts in introducing foods for food allergy prevention. Curr Opin Clin Nutr Metab Care. 2025 May 1;28(3):263-273. doi: 10.1097/MCO.0000000000001126. Epub 2025 Mar 7.

  PMID: 40072493 BACKGROUND

• Berni Canani R, Carucci L, Coppola S, D'Auria E, O'Mahony L, Roth-Walter F, Vassilopolou E, Agostoni C, Agache I, Akdis C, De Giovanni Di Santa Severina F, Faketea G, Greenhawt M, Hoffman K, Hufnagel K, Meyer R, Milani GP, Nowak-Wegrzyn A, Nwaru B, Padua I, Paparo L, Diego P, Reese I, Roduit C, Smith PK, Santos A, Untersmayr E, Vlieg-Boerstra B, Venter C. Ultra-processed foods, allergy outcomes and underlying mechanisms in children: An EAACI task force report. Pediatr Allergy Immunol. 2024 Sep;35(9):e14231. doi: 10.1111/pai.14231.

  PMID: 39254357 BACKGROUND

• Boden S, Lindam A, Venter C, Ulfsdotter RL, Domellof M, West CE. Diversity of complementary diet and early food allergy risk. Pediatr Allergy Immunol. 2025 Jan;36(1):e70035. doi: 10.1111/pai.70035.

  PMID: 39868464 BACKGROUND

• Harbottle Z, Malm Nilsson E, Venter C, Golding MA, Ekstrom S, Protudjer JLP. Parental Motivation for Introducing Babies' First Foods and Common Food Allergens. Nutrients. 2025 May 27;17(11):1812. doi: 10.3390/nu17111812.

  PMID: 40507081 BACKGROUND

• Samady W, Warren C, Bilaver LA, Zaslavsky J, Jiang J, Gupta R. Early Peanut Introduction Awareness, Beliefs, and Practices Among Parents and Caregivers. Pediatrics. 2023 Aug 1;152(2):e2022059376. doi: 10.1542/peds.2022-059376.

  PMID: 37476922 BACKGROUND

• Smith HG, Nimmagadda S, Gupta RS, Warren CM. Food allergen introduction practices and parent/caregiver attitudes based on family history of food allergy. Front Allergy. 2025 Mar 19;6:1562667. doi: 10.3389/falgy.2025.1562667. eCollection 2025.

  PMID: 40176928 BACKGROUND

Related Links

• The Health Belief Model of Behavior Change

MeSH Terms

Conditions

Food Hypersensitivity

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Sharon Chinthrajah, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Pulmonary Allergy and Critical Care Medicine

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: January 7, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)