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Could this treatment stop allergies before they start? new study in infants shows promise

NCT ID NCT05003804

Prevention Sponsor: Siolta Therapeutics, Inc. 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new treatment called STMC-103H in 283 newborn babies and infants who are at high risk for developing allergies (like eczema or food allergies) because of their family history. The goal was to see if the treatment is safe and can prevent these allergic conditions from starting. Babies received either the treatment or a placebo for up to 336 days, and researchers tracked how many developed eczema or other allergies.

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.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

283 people

The number who actually took part.

Started

Sep 2021

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

0 to 14 days

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: * All Parts (A1, A2, B) 1. Subject's parent(s)/legal representative(s) providing consent must be 18 years or older 2. Biological mother and/or biological father and/or full sibling(s), have a history of asthma, atopic dermatitis, food allergy, or allergic rhinitis as determined by the screening questionnaire 3. Subject's parent(s)/legal representative(s) (if appropriate according to local laws) is/are willing and able to give informed consent for participation in the study 4. Subject's parent(s)/legal representative(s) (if appropriate according to local laws) is/are willing and able, in the PI's opinion, to comply with all study requirements Part A1 Only Inclusion criteria 1-4 for all parts plus: 5 (A1). Subject is between 1 year and \< 6 years old at the time of enrollment Part A2 Only Inclusion criteria 1-4 for all parts plus: 5 (A2). Subject is between 28 days and \< 12 months of life at the time of enrollment 6 (A2). Subject's parent(s)/legal representative(s) do not plan to give probiotics (including infant formula that contain probiotics) to the subject during the trial Part B Only Inclusion criteria 1-4 for all parts plus: 5 (B). Subject is ≤ 14 days of life at the time of enrollment. Sites should make every effort to enroll newborns as soon as possible after birth. 6 (B). Subject has a birthweight ≥ 2.5 kg and ≤ 4.5 kg 7 (B). Subject's parent(s)/legal representative(s) do not plan to give probiotics (including infant formula that contain probiotics) to the subject from the time of birth to the end of the trial. Exclusion Criteria: * All Parts (A1, A2, B) 1. Subject's twin (or higher order multiple) is enrolled in STMC-103H-102 2. Subject has any congenital abnormalities or condition, significant disease, illness, physical exam finding, or disorder that, in the opinion of the PI, may put the subject at safety risk or is likely to hinder feeding or affect metabolism that may influence the results of the study. (Neonatal hyperbilirubinemia (jaundice), including jaundice that requires phototherapy, should not be considered exclusionary). 3. Subject is acutely ill or on systemic antibiotics at the time of enrollment 4. Subject is participating in another interventional clinical study involving investigational medication, formula, probiotic, or prebiotic use within 30 days (or five half-lives, whichever is longer) of this study 5. Subject has evidence of immune deficiency/immune compromise in the judgment of the investigator Part B Only Exclusion Criteria 1-5 for all parts plus: 6 (B). Subject was born at \< 35 weeks' gestation 7 (B). Biological maternal medical condition during the pregnancy that, in the opinion of the PI, may put the subject at risk because of participation in the study. (Maternal antibiotics during the time of delivery should not be considered exclusionary.)

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Conditions

The condition(s) this trial relates to.

Hypersensitivity, Immediate IgE responsiveness, atopic atopic eczema prevention target

As listed by the trial registrant

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

Atopic dermatitis Type 1 hypersensitivity

Contacts and locations

Locations

  • Arkansas Children's Research Institute

    Little Rock, Arkansas, 72202, United States

  • Boston Children's Hospital

    Boston, Massachusetts, 02215, United States

  • Centro de Neumologia Pediatrica

    Caguas, Puerto Rico, 00725, Puerto Rico

  • Children's Healthcare of Atlanta

    Atlanta, Georgia, 30329, United States

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Cincinnati Children's Hospital

    Cincinnati, Ohio, 45229, United States

  • Coastal Pediatrics Research

    Summerville, South Carolina, 29486, United States

  • Dell Medical School at UT Austin

    Austin, Texas, 78723, United States

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150, Australia

  • Johns Hopkins University School of Medicine

    Baltimore, MD, Maryland, 21205, United States

  • Lurie Children's Hospital

    Chicago, Illinois, 60611, United States

  • Monash Children's Hospital

    Clayton, Victoria, 3168, Australia

  • Mt. Sinai Jaffe Allergy Institute

    New York, New York, 10029, United States

  • Murdoch Children's Research Institute

    Parkville, Victoria, 3052, Australia

  • NYU Langone Fink Children's

    New York, New York, 10016, United States

  • Northwell Healthcare

    Great Neck, New York, 11021, United States

  • Queensland Children's Hospital

    South Brisbane, Queensland, 4101, Australia

  • Rady Children's Hospital - San Diego

    San Diego, California, 92123, United States

  • Riley Children's Health at University of Indiana

    Indianapolis, Indiana, 46202, United States

  • Seattle Allergy and Asthma Research Institute

    Seattle, Washington, 98115, United States

  • The Children's Hospital at Westmead

    Westmead, New South Wales, 2145, Australia

  • The Women's and Children's Hospital

    Adelaide, South Australia, 5000, Australia

  • Tribe Clinical Research

    Greenville, South Carolina, 29607, United States

  • UCLA Health

    Los Angeles, California, 90095, United States

  • UCSF Benioff Children's Hospital

    San Francisco, California, 94158, United States

  • UT Southwestern/Children's Health

    Dallas, Texas, 75235, United States

  • Univ. of Wisconsin-Madison/Jackson Research Group

    Madison, Wisconsin, 53792, United States

  • University of Arizona Health Sciences

    Tucson, Arizona, 85724, United States

  • University of Chicago Medicine

    Chicago, Illinois, 60637, United States

  • University of Michigan Health

    Ann Arbor, Michigan, 48104, United States

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

More trials for these conditions

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