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Allergic Disease Onset Prevention Study (adored)

Primary Purpose

Atopic Dermatitis, Type 1 Hypersensitivity

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
STMC-103H
Placebo
Sponsored by
Siolta Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atopic Dermatitis

Eligibility Criteria

0 Days - 14 Days (Child)All SexesAccepts Healthy Volunteers

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 ≤ 7 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.)

Sites / Locations

  • University of Arizona Health SciencesRecruiting
  • Arkansas Children's Research InstituteRecruiting
  • UCLA HealthRecruiting
  • Rady Children's Hospital - San DiegoRecruiting
  • UCSF Benioff Children's HospitalRecruiting
  • Children's Hospital ColoradoRecruiting
  • Children's Healthcare of AtlantaRecruiting
  • Lurie Children's HospitalRecruiting
  • University of Chicago MedicineRecruiting
  • Riley Children's Health at University of IndianaRecruiting
  • Johns Hopkins University School of MedicineRecruiting
  • Boston Children's HospitalRecruiting
  • University of Michigan HealthRecruiting
  • Northwell HealthcareRecruiting
  • NYU Langone Fink Children'sRecruiting
  • Mt. Sinai Jaffe Allergy InstituteRecruiting
  • University of Rochester Medical CenterRecruiting
  • Cincinnati Children's HospitalRecruiting
  • Tribe Clinical ResearchRecruiting
  • Coastal Pediatrics ResearchRecruiting
  • Dell Medical School at UT AustinRecruiting
  • UT Southwestern/Children's HealthRecruiting
  • Seattle Allergy and Asthma Research InstituteRecruiting
  • Univ. of Wisconsin-Madison/Jackson Research GroupRecruiting
  • The Children's Hospital at WestmeadRecruiting
  • Queensland Children's HospitalRecruiting
  • The Women's and Children's HospitalRecruiting
  • Monash Children's HospitalRecruiting
  • Murdoch Children's Research InstituteRecruiting
  • Fiona Stanley HospitalRecruiting
  • Centro de Neumologia PediatricaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

STMC-103H Part A1

Placebo Part A1

STMC-102H Part A2

Placebo Part A2

STMC-103H Part B

Placebo Part B

Arm Description

Once daily dosing with one capsule of STMC-103H mixed with milk, formula, or a milk product for 28 days

Once daily dosing with one capsule of placebo mixed with milk, formula, or a milk product for 28 days

Once daily dosing with one capsule of STMC-103H mixed with milk, formula, or a milk product for 28 days

Once daily dosing with one capsule of placebo mixed with milk, formula or a milk product for 28 days

Once daily dosing with one capsule of STMC-103H mixed with breastmilk, formula or a milk product for 336 days

Once daily dosing with one capsule of placebo mixed with breastmilk, formula or a milk product for 336 days

Outcomes

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
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)
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
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

Secondary Outcome Measures

Part B Secondary Efficacy Endpoint - physician-diagnosed atopic dermatitis
Incidence of physician-diagnosed atopic dermatitis
Part B - Secondary Efficacy Endpoint - atopic disease assessments
Proportion of subjects who develop any atopic disease (atopic dermatitis, food allergy, allergic rhinitis/conjunctivitis, asthma)
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
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
Part B Secondary Efficacy Endpoint - Time to atopic dermatitis diagnosis
Time to atopic dermatitis diagnosis by physician assessment
Part B Secondary Efficacy Endpoint - Time to first wheezing episode
Time to first wheezing episode by physician assessment
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
Part B Secondary Efficacy Endpoint - severity of atopic dermatitis by Severity Scoring Of Atopic Dermatitis (SCORAD) assessment
Severity of atopic dermatitis by SCORAD assessment
Part B Secondary Efficacy Endpoint - Severity of Wheezing Illness/Asthma
Severity of wheezing illness/asthma by Wheezing Severity Assessment
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
Part B Secondary Efficacy Endpoint - Total Serum IgE
Total serum IgE levels
Part B Secondary Efficacy Endpoint - Peripheral Eosinophil Counts
Peripheral eosinophil counts by automated differential

Full Information

First Posted
August 4, 2021
Last Updated
August 8, 2023
Sponsor
Siolta Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05003804
Brief Title
Allergic Disease Onset Prevention Study
Acronym
adored
Official Title
A Phase 1b/2, Randomized, Double-blind, Placebo-controlled, Multi-center Study of STMC-103H in Neonates and Infants at Risk for Developing Allergic Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Siolta Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Type 1 Hypersensitivity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Participants will be enrolled in a three-part sequential approach (Parts A1, A2, and B). Part A will enroll at risk participants of 1 year to less than 6 years of age; after safety review, Part A2 will enroll at risk participants of 1 month to less than 12 months of age; and after safety review, Part B will enroll at -risk participants between 0 and 14 days of life.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind, placebo-controlled
Allocation
Randomized
Enrollment
264 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
STMC-103H Part A1
Arm Type
Experimental
Arm Description
Once daily dosing with one capsule of STMC-103H mixed with milk, formula, or a milk product for 28 days
Arm Title
Placebo Part A1
Arm Type
Placebo Comparator
Arm Description
Once daily dosing with one capsule of placebo mixed with milk, formula, or a milk product for 28 days
Arm Title
STMC-102H Part A2
Arm Type
Experimental
Arm Description
Once daily dosing with one capsule of STMC-103H mixed with milk, formula, or a milk product for 28 days
Arm Title
Placebo Part A2
Arm Type
Placebo Comparator
Arm Description
Once daily dosing with one capsule of placebo mixed with milk, formula or a milk product for 28 days
Arm Title
STMC-103H Part B
Arm Type
Experimental
Arm Description
Once daily dosing with one capsule of STMC-103H mixed with breastmilk, formula or a milk product for 336 days
Arm Title
Placebo Part B
Arm Type
Placebo Comparator
Arm Description
Once daily dosing with one capsule of placebo mixed with breastmilk, formula or a milk product for 336 days
Intervention Type
Biological
Intervention Name(s)
STMC-103H
Intervention Description
STMC-103H is a live biotherapeutic product (LBP) containing a consortium of intestinal bacteria
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Powder containing excipients found in STMC-103H: magnesium stearate, mannitol and silicon dioxide.
Primary Outcome Measure Information:
Title
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
Description
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
Title
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.
Description
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
Title
Part B: Primary Efficacy Endpoint: Incidence of physician-diagnosed atopic dermatitis at 336 days
Description
Incidence of physician-diagnosed atopic dermatitis at 336 days in STMC-103H-treated subjects compared to placebo
Time Frame
Day 336
Secondary Outcome Measure Information:
Title
Part B Secondary Efficacy Endpoint - physician-diagnosed atopic dermatitis
Description
Incidence of physician-diagnosed atopic dermatitis
Time Frame
At days 168 and 672
Title
Part B - Secondary Efficacy Endpoint - atopic disease assessments
Description
Proportion of subjects who develop any atopic disease (atopic dermatitis, food allergy, allergic rhinitis/conjunctivitis, asthma)
Time Frame
At days 168, 336 and 672
Title
Part B Secondary Efficacy Endpoint - incidence of sensitization to food and aeroallergen
Description
Incidence of sensitization to food and aeroallergen as measured by specific serum IgE levels
Time Frame
At days 168, 336, and 672
Title
Part B Secondary Efficacy Endpoint - incidence of food allergy, allergic rhinitis/conjunctivitis, urticaria, and wheezing illness/asthma
Description
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
Title
Part B Secondary Efficacy Endpoint - Time to atopic dermatitis diagnosis
Description
Time to atopic dermatitis diagnosis by physician assessment
Time Frame
Through 672 days of study
Title
Part B Secondary Efficacy Endpoint - Time to first wheezing episode
Description
Time to first wheezing episode by physician assessment
Time Frame
Through 672 days of study
Title
Part B Secondary Efficacy Endpoint - severity of atopic dermatitis by Investigator Global Assessment x Body Surface Area (IGAxBSA) assessment
Description
Severity of atopic dermatitis by IGAxBSA assessment
Time Frame
At days 168, 336 and 672
Title
Part B Secondary Efficacy Endpoint - severity of atopic dermatitis by Severity Scoring Of Atopic Dermatitis (SCORAD) assessment
Description
Severity of atopic dermatitis by SCORAD assessment
Time Frame
At days 168, 336 and 672
Title
Part B Secondary Efficacy Endpoint - Severity of Wheezing Illness/Asthma
Description
Severity of wheezing illness/asthma by Wheezing Severity Assessment
Time Frame
At days 68, 336, and 672 days
Title
Part B Secondary Efficacy Endpoint - use of concomitant medications for allergic symptoms or diagnosis
Description
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
Title
Part B Secondary Efficacy Endpoint - Total Serum IgE
Description
Total serum IgE levels
Time Frame
At days 168, 336, and 672
Title
Part B Secondary Efficacy Endpoint - Peripheral Eosinophil Counts
Description
Peripheral eosinophil counts by automated differential
Time Frame
At day 336
Other Pre-specified Outcome Measures:
Title
Part B Key Exploratory Endpoint - Mean fecal concentration of 12,13-diHOME
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Days
Maximum Age & Unit of Time
14 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All Parts (A1, A2, B) Subject's parent(s)/legal representative(s) providing consent must be 18 years or older 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 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 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) Subject's twin (or higher order multiple) is enrolled in STMC-103H-102 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). Subject is acutely ill or on systemic antibiotics at the time of enrollment 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 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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth C Chesnut
Phone
4048030358
Email
echesnut@sioltatherapeutics.com
First Name & Middle Initial & Last Name or Official Title & Degree
Richard Shames, MD
Phone
6505750798
Email
rshames@sioltatherapeutics.com
Facility Information:
Facility Name
University of Arizona Health Sciences
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Cassell, MD
Email
heathercassell@arizona.edu
First Name & Middle Initial & Last Name & Degree
Megan Peterson
Email
mpeterson1@arizona.edu
Facility Name
Arkansas Children's Research Institute
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Scurlock, MD
Email
scurlockamym@uams.edu
First Name & Middle Initial & Last Name & Degree
Kim Norris
Email
NorrisKD@archildrens.org
Facility Name
UCLA Health
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Garcia-Lloret, MD
Email
Migarcia@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Alexis Stephens
Email
AVStephens@mednet.ucla.edu
Facility Name
Rady Children's Hospital - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Leonard, MD
Email
saleonard@health.ucsd.edu
First Name & Middle Initial & Last Name & Degree
Beth Kiernan
Email
ekiernan@rchsd.org
Facility Name
UCSF Benioff Children's Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Morna Dorsey, MD
Email
morna.dorsey@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Audrey Hernando
Email
audrey.hernando@ucsf.edu
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Greenhawt, MD
Email
matthew.greenhawt@childrenscolorado.org
First Name & Middle Initial & Last Name & Degree
Ariana Mayher
Email
ariana.mayher@childrenscolorado.org
Facility Name
Children's Healthcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Vickery, MD
Email
brian.p.vickery@emory.edu
First Name & Middle Initial & Last Name & Degree
Ashley Dulson
Email
ashley.dulson@choa.org
Facility Name
Lurie Children's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Lippner, MD
Email
elippner@luriechildrens.org
First Name & Middle Initial & Last Name & Degree
Michelle Catalano
Email
Mcatalano@luriechildrens.org
Facility Name
University of Chicago Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steve Handoyo, MD
Email
shandoy@peds.bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Iliana Mansur
Email
iliana.mansur@bsd.uchicago.edu
Facility Name
Riley Children's Health at University of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Girish Vitalpur, MD
Email
gvitalpu@iu.edu
First Name & Middle Initial & Last Name & Degree
Lori S Trotter
Email
lashivel@iu.edu
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Wood, MD
Email
rwood@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Michele Cootauco
Email
mcootau1@jhu.edu
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rima Rachid, MD
Email
rima.rachid@childrens.harvard.edu
First Name & Middle Initial & Last Name & Degree
Farida Abifarraj
Email
farida.abifarraj@childrens.harvard.edu
Facility Name
University of Michigan Health
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georgiana Sanders, MD
Email
gsanders@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Samantha Small
Email
srdushan@med.umich.edu
Facility Name
Northwell Healthcare
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Punita Ponda, MD
Email
pponda@northwell.edu
First Name & Middle Initial & Last Name & Degree
Aaqil Ali
Email
aali27@northwell.edu
Facility Name
NYU Langone Fink Children's
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Nowak-Wegrzyn, MD, PhD
Email
anna.nowak-wegrzyn@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Joseline Cruz-Vazquez
Email
joseline.cruzvasquez@nyulangone.org
Facility Name
Mt. Sinai Jaffe Allergy Institute
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Wang, MD
Email
julie.wang@mssm.edu
First Name & Middle Initial & Last Name & Degree
Jennifer Fishman
Email
jennifer.fishman@mssm.edu
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirsi Jarvinen-Seppo, MD, PhD
Email
kirsi_Jarvinen-seppo@urmc.rochester.edu
First Name & Middle Initial & Last Name & Degree
Allison Leadley
Email
allison_leadley@urmc.rochester.edu
Facility Name
Cincinnati Children's Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amal Assa'ad, MD
Email
amal.assaad@cchmc.org
First Name & Middle Initial & Last Name & Degree
Jennifer Jennings
Email
jennifer.jennings2@cchmc.org
Facility Name
Tribe Clinical Research
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Dobson, MD
Email
sdobson@tribe513.org
First Name & Middle Initial & Last Name & Degree
Cindy Kirkland
Email
ckirkland@tribecr.com
Facility Name
Coastal Pediatrics Research
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29486
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Stripling, MD
Email
stripling@cpakids.com
First Name & Middle Initial & Last Name & Degree
Julie Brenner
Email
brenner@cpakids.com
Facility Name
Dell Medical School at UT Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pooja Varshney, MD
Email
pvarshney@ascension.org
First Name & Middle Initial & Last Name & Degree
Rachel Smith
Email
rbsmith2@ascension.org
Facility Name
UT Southwestern/Children's Health
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Drew Bird, MD
Email
drew.bird@UTSouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Wanda McPhail
Email
wanda.mcphail@childrens.com
Facility Name
Seattle Allergy and Asthma Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Petroni, MD
Email
dpetroni@nwasthma.com
First Name & Middle Initial & Last Name & Degree
Marissa Nelson
Email
mnelsen@seattleallergy.com
Facility Name
Univ. of Wisconsin-Madison/Jackson Research Group
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Jackson, MD
Email
djj@medicine.wisc.edu
First Name & Middle Initial & Last Name & Degree
Tanya Watson
Email
tawatson@medicine.wisc.edu
Facility Name
The Children's Hospital at Westmead
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lara Ford, MD
Email
lara.ford@health.nsw.gov.au
First Name & Middle Initial & Last Name & Degree
Merilyn McArthur
Email
merilyn.mcarthur@health.nsw.gov.au
Facility Name
Queensland Children's Hospital
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jane Peake, MBBS, MRCP, FRACP
Email
jane.peake@health.qld.gov.au
First Name & Middle Initial & Last Name & Degree
Victoria Gibson
Email
victoria.gibson@health.qld.gov.au
Facility Name
The Women's and Children's Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Gold, MD
Email
michael.gold@sa.gov.au
First Name & Middle Initial & Last Name & Degree
Susan Fahy-Scheer
Email
susan.fahy-scheer@sa.gov.au
Facility Name
Monash Children's Hospital
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paxton Loke, MD
Email
paxton.loke@monashhealth.org
First Name & Middle Initial & Last Name & Degree
Melissa Batt
Email
melissa.batt@monashhealth.org
Facility Name
Murdoch Children's Research Institute
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirsten Perrett, MBBS, FRACP, PhD
Email
kirsten.perrett@rch.org.au
First Name & Middle Initial & Last Name & Degree
Danielle Kallianioti
Email
danielle.kallianioti@mcri.edu.au
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael O'Sullivan, MBBS, H D(ABMLI) FRACP FRCPA
Email
michael.o'sullivan@health.wa.gov.au
First Name & Middle Initial & Last Name & Degree
Sarah Miller
Email
sarah.miller3@health.wa.gov.au
Facility Name
Centro de Neumologia Pediatrica
City
Caguas
ZIP/Postal Code
00725
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Rodriguez-Santana, MD
Email
jr@pdasthma.com
First Name & Middle Initial & Last Name & Degree
Gonzalo U Serrano
Email
gonzalourielserrano@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Allergic Disease Onset Prevention Study

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