Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Massive study tracks 2500 kids from womb to uncover allergy roots

NCT ID NCT04798079

Knowledge-focused Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study enrolls 2500 pregnant women and follows their children from before birth up to age 3 (or 6 for those who continue). Researchers collect biosamples and environmental data to identify early-life markers and biological pathways that lead to food allergy and atopic dermatitis (eczema). The goal is to understand why some children develop these allergic conditions, not to test a new treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could reveal early-life markers and biological pathways that predict food allergy and eczema, pointing toward future prevention strategies.
What could go wrong
This is an observational study, not testing a treatment. It may not identify clear risk markers, and findings may not lead to direct interventions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 2,500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2021

Expected to finish

Jul 2032

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population will include pregnant women, their offspring from birth until age 3 years or 6 years, and the offspring's biological father. Although biological fathers will be recruited, their enrollment is not required. The women will be recruited from OB/GYN and prenatal clinics and offices. Other than the eligibility criteria listed, women will not be selected by any criteria or characteristics. The intent is to recruit a study population of children of varying risks with regards to the development of allergic diseases. The rationale is to identify risk factors in the population for the development of allergic disease. Selection of pregnant women whose offspring are at an elevated risk of allergic disease would prevent the study of the risk factors used to select the women.

Ages

0 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Pregnant Women- Pregnant women who meet all of the following criteria are eligible for enrollment as study participants: 1. Age 18 years or older 2. Able to understand the oral and written instructions associated with study visits and procedures and provide informed consent 3. Pregnant at any stage 4. Planning to give birth at a study-site designated center 5. Agrees to enroll offspring into the study at birth 6. In the case of multiple gestation, agrees to enroll only one child who will be selected by randomized birth order Biological Fathers- Biological fathers who meet all of the following criteria are eligible for enrollment as study participants: 1. Age 18 years or older 2. Able to understand the oral and written instructions associated with study visits and procedures and provide informed consent Exclusion Criteria: Pregnant Women- Pregnant women who meet any of these criteria are not eligible for enrollment: 1. Inability or unwillingness to comply with study protocol 2. Serious pregnancy complication (in the judgement of the investigator) prior to enrollment 3. Fetus has a major chromosomal anomaly 4. Plans to move and would not be available for in-person visits at a study site 5. Plans to give up her child for adoption at birth 6. Pregnancy is the result of an egg donation Infants- Infants who meet any of these criteria are not eligible for enrollment: 1. Delivered earlier than 34 weeks of gestation 2. Sibling already enrolled 3. Born with a significant birth defect or medical condition, and in the judgment of the investigators, participation is not in the infant's best interest Biological Father- 1\. Biological fathers who are unable or unwilling to comply with the study protocol as it pertains to the biological father's participation are not eligible for enrollment ----Note Regarding Legal Guardians who are not the Biological Parents: 1. At screening for enrollment of either the mother or the child, if the biological mother intends to give the infant up for adoption, neither the mother nor the child are eligible for enrollment 2. If the biological mother gives up legal guardianship of the child during the child's follow-up period, the child may remain enrolled as long as the new legal guardian: * Agrees to meet the child's study requirements, and * Provides written informed consent for the child's continued participation. 3. Throughout the protocol where it refers to the mother, father, or parent answering questionnaires about the child or collecting samples from the child and the child's primary home, the legal guardian who provides consent for the child's participation may complete those procedures

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Allergic diseases are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

allergic disease atopic eczema food allergy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Allergic diseases Atopic dermatitis Food allergy

Contacts and locations

Locations

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Henry Ford Health System, Division of Allergy and Immunology

    Detroit, Michigan, 48202, United States

  • Johns Hopkins Children's Center, Department of Allergy & Immunology

    Baltimore, Maryland, 21287, United States

  • Kravis Children's Hospital, Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Massachusetts General Hospital, Translational and Clinical Research Center

    Boston, Massachusetts, 02114, United States

  • National Jewish Health

    Denver, Colorado, 80206, United States

  • North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology

    Chapel Hill, North Carolina, 27599, United States

  • Northwestern University Feinberg School of Medicine: Dept of Dermatology

    Chicago, Illinois, 60611, United States

  • Sean N. Parker Center for Allergy & Asthma Research at Stanford University

    Stanford, California, 94040, United States

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

  • University of Wisconsin School of Medicine and Public Health

    Madison, Wisconsin, 53792, United States

  • Vanderbilt University Medical Center Department of Pediatrics Division of Pediatric Allergy, Immunology, and Pulmonary Medicine

    Nashville, Tennessee, 37232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.