A Phase 1/2 interventional study of STMC-103H and Placebo in Atopic Dermatitis and Type 1 Hypersensitivity, sponsored by Siolta Therapeutics, Inc.. Completed at 31 sites in 3 countries. Open to participants aged 0 Days to 14 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-20.
Sponsored by Siolta Therapeutics, Inc. · Phase 1/2, Interventional, and Prevention
This is a Phase 1b/2, randomized, double-blind, multi-center study to evaluate the safety, tolerability, and preliminary clinical efficacy of STMC-103H in neonates and infants at risk for developing allergic disease (Type 1 hypersensitivity). Subjects will be enrolled in a three-part sequential approach. Participants in the safety-run portion of the study (Part A1: 1 year to \<6 years of age and A2: 1 month to \<12 months of age) will receive 28 days of treatment with STMC-103H or placebo, followed by 28 days of follow-up. A Data and Safety Monitoring Committee (DSMC) will review safety data after all patients in each part complete 28 days of therapy prior to enrolling the next part. After A2, Part B will enroll 224 patients for 336 days of treatment with STMC-103H or placebo, followed by 336 days of follow-up. Stool, blood, and optional samples will be collected in Parts A2 and part B. Primary safety endpoints are frequency, type and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs), as well as findings on physical exams, vitals, and safety laboratories. The primary efficacy endpoint is incidence of physician-diagnosed atopic dermatitis at day 336.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's enrollment of 283 is above the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Siolta Therapeutics, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
All Parts (A1, A2, B)
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)
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.)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Once daily dosing with one capsule of STMC-103H mixed with milk, formula, or a milk product for 28 days
Biological: STMC-103H
Once daily dosing with one capsule of placebo mixed with milk, formula, or a milk product for 28 days
Biological: Placebo
Once daily dosing with one capsule of STMC-103H mixed with milk, formula, or a milk product for 28 days
Biological: STMC-103H
Once daily dosing with one capsule of placebo mixed with milk, formula or a milk product for 28 days
Biological: Placebo
Once daily dosing with one capsule of STMC-103H mixed with breastmilk, formula or a milk product for 336 days
Biological: STMC-103H
Once daily dosing with one capsule of placebo mixed with breastmilk, formula or a milk product for 336 days
Biological: Placebo
STMC-103H is a live biotherapeutic product (LBP) containing a consortium of intestinal bacteria
Powder containing excipients found in STMC-103H: magnesium stearate, mannitol and silicon dioxide.
Part A1 and A2: Assess safety and tolerability of STMC-103H in children and infants at risk for development of allergic disease by assessing adverse events (AE), serious adverse events (SAE), and AEs of special interest
Frequency, type, and severity of AEs and SAEs, including AEs of special interest (AESI) as in Appendix 9 (Adverse Events of Special Interest) and Appendix 10 (Adverse Event Grading Scale)
Time frame: Through 56 days of study
Part B: Assess the safety, tolerability of STMC-103H in neonate and infants subjects at risk for development of atopic disease by monitoring AEs, SAEs, AESI, physical exam findings, and clinical safety laboratories.
Frequency, type and severity of AEs, SAEs, and AESIs as in Appendix 9 (Adverse Events of Special Interest) and Appendix 10 (Adverse Event Grading Scale), as well as clinically significant findings on physical examinations including growth (length, weight, height and head circumference) and vital signs (RR, HR, and temperature); clinical safety laboratories including complete blood count with manual differential and blood chemistry
Time frame: Through 672 days of study
Part B: Primary Efficacy Endpoint: Incidence of physician-diagnosed atopic dermatitis at 336 days
Incidence of physician-diagnosed atopic dermatitis at 336 days in STMC-103H-treated subjects compared to placebo
Time frame: Day 336
Part B Secondary Efficacy Endpoint - physician-diagnosed atopic dermatitis
Incidence of physician-diagnosed atopic dermatitis
Time frame: At days 168 and 672
Part B - Secondary Efficacy Endpoint - atopic disease assessments
Proportion of subjects who develop any atopic disease (atopic dermatitis, food allergy, allergic rhinitis/conjunctivitis, asthma)
Time frame: At days 168, 336 and 672
Part B Secondary Efficacy Endpoint - incidence of sensitization to food and aeroallergen
Incidence of sensitization to food and aeroallergen as measured by specific serum IgE levels
Time frame: At days 168, 336, and 672
Part B Secondary Efficacy Endpoint - incidence of food allergy, allergic rhinitis/conjunctivitis, urticaria, and wheezing illness/asthma
Incidence of physician-diagnosed food allergy, allergic rhinitis/conjunctivitis, urticaria and wheezing illnesses/asthma using physician assessment, Allergic Disease Assessment and Diagnosis questionnaire, and Allergic Disease Diagnostic Criteria \& Severity Evaluation
Time frame: At days 168, 336, and 672
Part B Secondary Efficacy Endpoint - Time to atopic dermatitis diagnosis
Time to atopic dermatitis diagnosis by physician assessment
Time frame: Through 672 days of study
Part B Secondary Efficacy Endpoint - Time to first wheezing episode
Time to first wheezing episode by physician assessment
Time frame: Through 672 days of study
Part B Secondary Efficacy Endpoint - severity of atopic dermatitis by Investigator Global Assessment x Body Surface Area (IGAxBSA) assessment
Severity of atopic dermatitis by IGAxBSA assessment
Time frame: At days 168, 336 and 672
Part B Secondary Efficacy Endpoint - severity of atopic dermatitis by Severity Scoring Of Atopic Dermatitis (SCORAD) assessment
Severity of atopic dermatitis by SCORAD assessment
Time frame: At days 168, 336 and 672
Part B Secondary Efficacy Endpoint - Severity of Wheezing Illness/Asthma
Severity of wheezing illness/asthma by Wheezing Severity Assessment
Time frame: At days 68, 336, and 672 days
Part B Secondary Efficacy Endpoint - use of concomitant medications for allergic symptoms or diagnosis
Concomitant medications prescribed/used for allergic symptoms or diagnosis and use of rescue medications for atopic dermatitis and wheezing/asthma
Time frame: Through 672 days of study
Part B Secondary Efficacy Endpoint - Total Serum IgE
Total serum IgE levels
Time frame: At days 168, 336, and 672
Part B Secondary Efficacy Endpoint - Peripheral Eosinophil Counts
Peripheral eosinophil counts by automated differential
Time frame: At day 336
Part B Key Exploratory Endpoint - Mean fecal concentration of 12,13-diHOME
Mean fecal concentration of 12,13-diHOME measured in stool sample in STMC-103H arm as compared to placebo arm
Time frame: At day 336
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2021 to primary completion in Nov 2024, 38 months.
Of 25 industry-sponsored phase 1/2 interventional studies under Dermatitis, Atopic, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 38. This study's 38 months is above that.
Counting every sponsor, half of 29 studies reached it within 22 months; a quarter within 8 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Siolta Therapeutics, Inc.