264 Participants Needed

STMC-103H for Allergies

(adored Trial)

Recruiting at 30 trial locations
EC
RS
BV
Overseen ByBrian Vickery, MD
Age: < 18
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Siolta Therapeutics, Inc.

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new treatment called STMC-103H to see if it can help prevent allergic diseases in young children. The study focuses on babies and infants who are at risk of developing allergies. The treatment aims to improve their immune system's response to allergens, potentially reducing conditions like atopic dermatitis.

Are You a Good Fit for This Trial?

This trial is for newborns and infants at risk of developing allergies, with family history of asthma or allergic conditions. It's not for those with congenital abnormalities, significant diseases, immune deficiencies, or born prematurely (<35 weeks' gestation). Participants must be between 28 days to less than 6 years old depending on the study part.

Inclusion Criteria

I will not give my child probiotics during Part A2 of the trial.
My birthweight was between 2.5 kg and 4.5 kg.
My newborn is less than 14 days old.
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Exclusion Criteria

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) (Part B)
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
Subject's twin (or higher order multiple) is enrolled in STMC-103H-102
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A1 and A2

Participants receive STMC-103H or placebo for 28 days

4 weeks
Daily dosing

Follow-up Part A1 and A2

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Part B

Participants receive STMC-103H or placebo for 336 days

48 weeks
Daily dosing

Follow-up Part B

Participants are monitored for safety and effectiveness after treatment

48 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Placebo
  • STMC-103H
Trial Overview The trial tests STMC-103H against a placebo in preventing allergy development. It has three parts: initial safety-run (28 days treatment), followed by review; then a larger group treated for almost a year. Safety and effectiveness are monitored through adverse events and diagnosis rates.
How Is the Trial Designed?
6Treatment groups
Experimental Treatment
Placebo Group
Group I: STMC-103H Part BExperimental Treatment1 Intervention
Group II: STMC-103H Part A1Experimental Treatment1 Intervention
Group III: STMC-102H Part A2Experimental Treatment1 Intervention
Group IV: Placebo Part A1Placebo Group1 Intervention
Group V: Placebo Part BPlacebo Group1 Intervention
Group VI: Placebo Part A2Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Siolta Therapeutics, Inc.

Lead Sponsor

Trials
2
Recruited
320+
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