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

NCT07321522 | Not Yet 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 (3)

• Compare the infant age at which allergenic foods were introduced

  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.

  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.

  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.

Study Arms (2)

Standard of Care

NO INTERVENTION

The participants will be provided with three sets of educational materials to learn about early introduction of food allergens.

Enhanced Educational Opportunities

EXPERIMENTAL

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; Behavioral: In person feeding session

Interventions

In person feeding session BEHAVIORAL

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.

Enhanced Educational Opportunities

Educational Sessions and Opportunities on Early Introduction and Sustained Ingestion BEHAVIORAL

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.

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 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

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 Top 9 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

Location

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

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

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 (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)