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STMC-103H for Allergies (adored Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by Siolta Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 A2)
Subject has a birthweight ≥ 2.5 kg and ≤ 4.5 kg (Part B)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at days 168, 336 and 672
Awards & highlights

adored Trial Summary

This trial is testing a new drug to see if it's safe and effective in treating allergic disease in infants and young children.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects include reactions typical to new medications such as digestive issues, skin rashes, or respiratory symptoms. Serious side effects will be closely monitored including any impact on growth or overall health during the first year.

adored Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I will not give my child probiotics during Part A2 of the trial.
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My birthweight was between 2.5 kg and 4.5 kg.
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My newborn is less than 14 days old.
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I am between 1 and 6 years old.
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My parent or legal guardian is over 18 and can give consent.
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My child will not receive probiotics from birth until the trial ends.

adored Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at days 168, 336 and 672
This trial's timeline: 3 weeks for screening, Varies for treatment, and at days 168, 336 and 672 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
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.
Dermatitis, Atopic
Secondary outcome measures
Part B - Secondary Efficacy Endpoint - atopic disease assessments
Part B Secondary Efficacy Endpoint - Peripheral Eosinophil Counts
Part B Secondary Efficacy Endpoint - Severity of Wheezing Illness/Asthma
+9 more
Other outcome measures
Feces

adored Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: STMC-103H Part BExperimental Treatment1 Intervention
Once daily dosing with one capsule of STMC-103H mixed with breastmilk, formula or a milk product for 336 days
Group II: STMC-103H Part A1Experimental Treatment1 Intervention
Once daily dosing with one capsule of STMC-103H mixed with milk, formula, or a milk product for 28 days
Group III: STMC-102H Part A2Experimental Treatment1 Intervention
Once daily dosing with one capsule of STMC-103H mixed with milk, formula, or a milk product for 28 days
Group IV: Placebo Part A1Placebo Group1 Intervention
Once daily dosing with one capsule of placebo mixed with milk, formula, or a milk product for 28 days
Group V: Placebo Part BPlacebo Group1 Intervention
Once daily dosing with one capsule of placebo mixed with breastmilk, formula or a milk product for 336 days
Group VI: Placebo Part A2Placebo Group1 Intervention
Once daily dosing with one capsule of placebo mixed with milk, formula or a milk product for 28 days

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Siolta Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

Placebo (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05003804 — Phase 1 & 2
Allergy Research Study Groups: STMC-102H Part A2, Placebo Part A1, STMC-103H Part A1, Placebo Part B, STMC-103H Part B, Placebo Part A2
Allergy Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05003804 — Phase 1 & 2
Placebo (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05003804 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the specific requirements for participants in this test?

"This clinical trial is seeking 264 participants with dermatitis between the ages of 0 Days and 7 Days. In order to be eligible, candidates must meet the following criteria: 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, All Parts (A1, A2, B), Subject's parent(s)/legal representative(s) providing consent must be 18 years or older, Subject's parent(s)/legal representative(s) (if appropriate according to local laws) is/"

Answered by AI

Does the age requirement for this experiment end at 64 years old?

"This particular study is designed for infants aged 0 to 7 days old. Out of the 512 total trials, this age group has 184 studies dedicated to them while there are 328 for people over the age 65."

Answered by AI

Are there any current vacancies for patients in this clinical trial?

"Yes, that is correct. The clinical trial in question is still recruiting patients, having originally been posted on September 1st, 2021. It was last edited on September 2nd of this year. They are currently looking for 264 individuals across 20 different locations."

Answered by AI

At how many places is this trial done?

"In total, 23 clinical trial sites are running this experiment. The largest concentration of hospitals is in San Francisco, California with Arkansas Children's Research Institute in Little Rock and University of Arizona Health Sciences in Tucson also participating."

Answered by AI

What goals does this experiment aim to achieve?

"The sponsor of this clinical trial, Siolta Therapeutics, Inc., is measuring the primary outcome over a 336 day period. The primary outcome is safety and tolerability in children and infants who are at risk for developing allergic disease. This will be done by assessing adverse events (AE), serious adverse events (SAE), and AEs of special interest. Additionally, the trial will evaluate secondary outcomes including time to first wheezing episode, physician-diagnosed atopic dermatitis, and proportion of subjects who develop any atopic disease."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Children's Healthcare of Atlanta
UCSF Benioff Children's Hospital
How many prior treatments have patients received?
2

Why did patients apply to this trial?

athlete, breastfed, home birth, excellent diet and lifestyle. eczema and dry skin at 3 months of age, allergic rhinitis and mom desperate to stop the atopic march.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Allergic Disease Onset Prevention Study
2021. "Allergic Disease Onset Prevention Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05003804.
All > Penicillin Allergy > Allergy
~42 spots leftby Nov 2024
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