Food AllergyNCT07321522
Early Introduction and Sustained Ingestion (EISI) Using Two Educational Opportunities in Infants
A study testing Education and Opportunities on Early Introduction and Clinician Supervised Feeding of Known Allergenic Food in people with Food Allergy, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 11 monthsHealthy volunteers can take part
- Conditions the study is for
- Food Allergy
- What is being tested?
- Education and Opportunities on Early Introduction and Clinician Supervised Feeding of Known Allergenic Food
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2026to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 11 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Stanford, California, 94305
SNP Center Inquiry, 650-521-7237, snpcenterallergy_inquiry@stanford.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Food Allergy
- Being tested
- Education and Opportunities on Early Introduction, Clinician Supervised Feeding of Known Allergenic Food
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and Opportunities on Early IntroductionBehavioural
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 FoodBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Education and Opportunities on Early Introduction; Behavioral: Clinician Supervised Feeding of Known Allergenic Food |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to six months.
Compare the allergenic food intake frequency.
Characterize diet diversity between the standard of care arm and the experimental arm.
Measured: At the start of intervention and month 1, month 2, month 3, month 4, and month 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start30 Jun 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, R. Sharon Chinthrajah, Stanford University
- Investigators
- Sharon Chinthrajah, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07321522
- Sponsor's protocol ID
- 81307
- Status last verified
- Jun 2026
- First submitted
- 15 Dec 2025
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36596337Gupta 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.
PubMed 24042236Togias 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.
PubMed 28065278Du 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.
PubMed 25705822Perkin 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.
PubMed 26896232Natsume 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.
PubMed 27939035Venter 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.
PubMed 40072493Berni 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.
PubMed 39254357Boden 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.
PubMed 39868464Harbottle 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.
PubMed 40507081Samady 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.
PubMed 37476922Smith 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.
PubMed 40176928
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Introduction and Sustained Ingestion (EISI) Using Two Educational Opportunities - A Pilot Study
- ClinicalTrials.gov ID
- NCT07321522
- Acronym / sponsor ID
- 81307
- Conditions
- Food Allergy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Education and Opportunities on Early Introduction, Behavioral: Clinician Supervised Feeding of Known Allergenic FoodThe 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. |
Who may qualify
- Ages
- 4 to 11 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education and Opportunities on Early IntroductionThe 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. | Behavioural | Enhanced Educational Opportunities |
| Clinician Supervised Feeding of Known Allergenic FoodClinician 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. | Behavioural | Enhanced Educational Opportunities |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Background: PubMed 36596337Warren 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.
- Background: PubMed 24042236Gupta 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.
- Background: PubMed 28065278Togias 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.
- Background: PubMed 25705822Du 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.
- Background: PubMed 26896232Perkin 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.
- Background: PubMed 27939035Natsume 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.
- Background: PubMed 40072493Venter 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.
- Background: PubMed 39254357Berni 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.
- Background: PubMed 39868464Boden 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.
- Background: PubMed 40507081Harbottle 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.
- Background: PubMed 37476922Samady 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.
- Background: PubMed 40176928Smith 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.
- The Health Belief Model of Behavior ChangeLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Food Allergy
Not yet recruiting
Oral Immunotherapy for Children With Peanut Allergy
Peanut Allergic Subjects, Peanut Allergies
RecruitingObservational study
Study of Oral Food Challenge Biomarkers (SAFER)
Allergy
Active, not recruitingObservational study
EPAP, Interviewstudy
Food Allergy, Food Allergy Peanut
Not yet recruiting
Oral Immunotherapy for Children With Egg Allergy
Egg Allergy, Egg Hypersensitivity
RecruitingPhase 2
Efficacy of Tezepelumab in Peanut Oral Immunotherapy
Peanut Allergy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sharon Chinthrajah, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and Opportunities on Early Introduction and Clinician Supervised Feeding of Known Allergenic Food in people with Food Allergy, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the infant age at which allergenic foods were introduced (time frame: Baseline up to six months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07321522, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.