Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
283 participants
INTERVENTIONAL
2021-09-01
2025-10-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Penicillin Allergy Testing and Resensitization Rate
NCT03942731
Evaluation of Skin Testing Reagents for Penicillin Allergy
NCT01818336
Clinical Evaluation of T.R.U.E. TEST Panel 3.2 in Children and Adolescents
NCT01518348
A Study to Assess the Biological Potency of Peanut Allergen Extract in Adolescent and Adult Peanut Allergic Subjects
NCT03352726
Characterization of the Molecular Mechanisms Involved in Delayed-Type Hypersensitivity Reactions to House Dust Mite, Diphencyprone, Nickel, and Tuberculin Purified Protein Derivative in Healthy Volunteers
NCT03625219
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
STMC-103H Part A1
Once daily dosing with one capsule of STMC-103H mixed with milk, formula, or a milk product for 28 days
STMC-103H
STMC-103H is a live biotherapeutic product (LBP) containing a consortium of intestinal bacteria
Placebo Part A1
Once daily dosing with one capsule of placebo mixed with milk, formula, or a milk product for 28 days
Placebo
Powder containing excipients found in STMC-103H: magnesium stearate, mannitol and silicon dioxide.
STMC-102H Part A2
Once daily dosing with one capsule of STMC-103H mixed with milk, formula, or a milk product for 28 days
STMC-103H
STMC-103H is a live biotherapeutic product (LBP) containing a consortium of intestinal bacteria
Placebo Part A2
Once daily dosing with one capsule of placebo mixed with milk, formula or a milk product for 28 days
Placebo
Powder containing excipients found in STMC-103H: magnesium stearate, mannitol and silicon dioxide.
STMC-103H Part B
Once daily dosing with one capsule of STMC-103H mixed with breastmilk, formula or a milk product for 336 days
STMC-103H
STMC-103H is a live biotherapeutic product (LBP) containing a consortium of intestinal bacteria
Placebo Part B
Once daily dosing with one capsule of placebo mixed with breastmilk, formula or a milk product for 336 days
Placebo
Powder containing excipients found in STMC-103H: magnesium stearate, mannitol and silicon dioxide.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
STMC-103H
STMC-103H is a live biotherapeutic product (LBP) containing a consortium of intestinal bacteria
Placebo
Powder containing excipients found in STMC-103H: magnesium stearate, mannitol and silicon dioxide.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
5 (A1). Subject is between 1 year and \< 6 years old at the time of enrollment
Part A2 Only
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
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
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
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.)
0 Days
14 Days
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Siolta Therapeutics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Arizona Health Sciences
Tucson, Arizona, United States
Arkansas Children's Research Institute
Little Rock, Arkansas, United States
UCLA Health
Los Angeles, California, United States
Rady Children's Hospital - San Diego
San Diego, California, United States
UCSF Benioff Children's Hospital
San Francisco, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Lurie Children's Hospital
Chicago, Illinois, United States
University of Chicago Medicine
Chicago, Illinois, United States
Riley Children's Health at University of Indiana
Indianapolis, Indiana, United States
Johns Hopkins University School of Medicine
Baltimore, MD, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
University of Michigan Health
Ann Arbor, Michigan, United States
Northwell Healthcare
Great Neck, New York, United States
NYU Langone Fink Children's
New York, New York, United States
Mt. Sinai Jaffe Allergy Institute
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Tribe Clinical Research
Greenville, South Carolina, United States
Coastal Pediatrics Research
Summerville, South Carolina, United States
Dell Medical School at UT Austin
Austin, Texas, United States
UT Southwestern/Children's Health
Dallas, Texas, United States
Seattle Allergy and Asthma Research Institute
Seattle, Washington, United States
Univ. of Wisconsin-Madison/Jackson Research Group
Madison, Wisconsin, United States
The Children's Hospital at Westmead
Westmead, New South Wales, Australia
Queensland Children's Hospital
South Brisbane, Queensland, Australia
The Women's and Children's Hospital
Adelaide, South Australia, Australia
Monash Children's Hospital
Clayton, Victoria, Australia
Murdoch Children's Research Institute
Parkville, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Centro de Neumologia Pediatrica
Caguas, Puerto Rico, Puerto Rico
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STMC-103H-102
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.