Clinical Trials

Systems Biology of Early Atopy

Study Purpose

The goal of this study is to establish a birth cohort that collects prenatal and early life biosamples and environmental samples and rigorously phenotypes young children for food allergy and Atopic Dermatitis (AD) to identify prenatal and early life markers of high risk for food allergy and AD, as well as biological pathways (endotypes) that result in these conditions. Primary Objectives:

- To study the role and interrelationships of established and novel clinical, environmental, biological, and genetic prenatal and early-life factors in the development of allergic diseases through age 3 years, with an emphasis on atopic dermatitis and food allergy.

- To apply systems biology to identify mechanisms and biomarkers underlying the development of food allergy, atopic dermatitis, and their endotypes.

- To collect, process, and assay or store environmental and biological samples for current and future use in the study of allergic disease development

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	0 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

Pregnant Women- Pregnant women who meet all of the following criteria are eligible for enrollment as study participants: 1. Age 18 years or older. 2. Able to understand the oral and written instructions associated with study visits and procedures and provide informed consent. 3. Pregnant at any stage. 4. Planning to give birth at a study-site designated center. 5. Agrees to enroll offspring into the study at birth. 6. In the case of multiple gestation, agrees to enroll only one child who will be selected by randomized birth order. Biological Fathers- Biological fathers who meet all of the following criteria are eligible for enrollment as study participants: 1. Age 18 years or older. 2. Able to understand the oral and written instructions associated with study visits and procedures and provide informed consent.

Exclusion Criteria:

Pregnant Women- Pregnant women who meet any of these criteria are not eligible for enrollment: 1. Inability or unwillingness to comply with study protocol. 2. Serious pregnancy complication (in the judgement of the investigator) prior to enrollment. 3. Fetus has a major chromosomal anomaly. 4. Plans to move and would not be available for in-person visits at a study site. 5. Plans to give up her child for adoption at birth. 6. Pregnancy is the result of an egg donation. Infants- Infants who meet any of these criteria are not eligible for enrollment: 1. Delivered earlier than 34 weeks of gestation. 2. Sibling already enrolled. 3. Born with a significant birth defect or medical condition, and in the judgment of the investigators, participation is not in the infant's best interest. Biological Father- 1. Biological fathers who are unable or unwilling to comply with the study protocol as it pertains to the biological father's participation are not eligible for enrollment. ----Note Regarding Legal Guardians who are not the Biological Parents: 1. At screening for enrollment of either the mother or the child, if the biological mother intends to give the infant up for adoption, neither the mother nor the child are eligible for enrollment. 2. If the biological mother gives up legal guardianship of the child during the child's follow-up period, the child may remain enrolled as long as the new legal guardian:

- Agrees to meet the child's study requirements, and.

- Provides written informed consent for the child's continued participation.

3. Throughout the protocol where it refers to the mother, father, or parent answering questionnaires about the child or collecting samples from the child and the child's primary home, the legal guardian who provides consent for the child's participation may complete those procedures

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04798079
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Corinne Keet, MD,MS,PhDScott H. Sicherer, MD
Principal Investigator Affiliation	Div.of Pediatric Allergy, Immunology and Rheumatology, Dept. of Pediatrics, Johns Hopkins School of MedicineDiv. of Pediatric Allergy and Immunology, Jaffe Food Allergy Institute,Dept. of Pediatrics, Icahn School of Medicine at Mount Sinai
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	NIH, Other, Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Allergic Diseases, Food Allergy, Atopic Dermatitis

Additional Details

This is a prospective cohort study in which pregnant women (at any stage of pregnancy), the offspring's biologic father, and the offspring will be enrolled at study sites and the offspring will be observed from birth to age 3 years. The enrollment goal is at least 2500 pregnant women who agree to enroll their offspring at birth. Enrollment of biological fathers will be attempted; however, enrollment of the mother or child is not dependent on enrollment of the biological father. During the study, biological and environmental samples and questionnaire information will be collected from the parents and the children, and the children will be assessed for allergic diseases at clinic visits at ages 2, 5, 12, 24, and 36 months.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Arkansas Children's Hospital, Little Rock, Arkansas

Status

Recruiting

Address

Arkansas Children's Hospital

Little Rock, Arkansas, 72202

Site Contact

Cassandra Thomas

ThomasC1@archildrens.org

501-364-5178

Stanford, California

Status