- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07828405
Genes, Soy Isoflavones, and Virus (GSV)
14 de septiembre de 2026 actualizado por: Ann & Robert H Lurie Children's Hospital of Chicago
Genes, Soy Isoflavones, and Virus - Preventing Airway Remodeling, Asthma, and Wheezing Study
In this study, we will assess whether children without established asthma who have a variation in the switch for the PAI-1 gene will have higher PAI-1 levels and remodeling / allergic inflammatory pathways in their airways than children who do not have the gene.
We will also determine if soy isoflavones given when presenting for an acute respiratory illness can decrease these changes.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
Pediatric asthma affects 8.3% of U.S. children, accounting for 5.92 billion dollars of U.S. health care expenditure annually.
Approximately 80% of the children who progress to have asthma will have wheeze in early childhood, suggesting that primary prevention should target infancy.
In particular, severe early life viral lower respiratory tract infection (LRTI) shows strong associations with asthma development which are modified by genetic predisposition.1-5
A gain of function plasminogen activator inhibitor-1 (PAI-1) promoter variant is present in up to 60% of the population who develop asthma in either homozygote or heterozygote form.
If children with ≥1 copy of the PAI-1 risk allele had a respiratory viral illness requiring a physician visit before 2 years old, these subjects had a 12-fold (any virus) to 18-fold (self-reported Respiratory Syncytial Virus (RSV)) increased risk of developing asthma.
PAI-1 production increases in the airway at the time of a viral illness and promotes both fibrosis and an allergic airway milieu.
We have found that soy isoflavones decrease the production of PAI-1 and decrease rates of asthma exacerbations by 75% in subjects with the risk gene.
This pilot will allow for preliminary data to determine if on-demand treatment with soy isoflavone improves epithelial integrity and decreases Th2 airway responses if dosed with onset of illness.
This would establish the viability of on demand treatment for early life viral illness which may modulate acute outcomes.
In this study, we will assess whether children without established asthma who have the PAI-1 genotype will have higher PAI-1 levels and remodeling / allergic inflammatory pathways in their airways than children who do not have the genotype.
We will also determine if soy isoflavones given when presenting for an acute respiratory illness can decrease these changes in children both with and without the genotype.
Finally, we will also study these questions in a lung organoid / Air Liquid Interface (ALI) model with cells from subjects with the risk allele, which will allow us to compare soy isoflavone pre-inoculation treatment with treatment post infection in a controlled experiment.
These data would be essential to set up the team to assess the effects of on demand treatment of children with LRTI irrespective of asthma after presentation to the ED.
This would be an important step forward compared to chronic treatment in high-risk populations which will have barriers to implementation.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
60
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Caroline Merck, MPH
- Número de teléfono: 312-227-2469
- Correo electrónico: cmerck@luriechildrens.org
Copia de seguridad de contactos de estudio
- Nombre: Aliviya Schulze, BS
- Número de teléfono: 312-227-5391
- Correo electrónico: aschulze@luriechildrens.org
Ubicaciones de estudio
-
-
Illinois
-
Chicago, Illinois, Estados Unidos, 60311
- Ann & Robert H Lurie Children's hospital of Chicago
-
Contacto:
- Aliviya Schulze, BS
- Número de teléfono: 312-227-5391
- Correo electrónico: aschulze@luriechildrens.org
-
Contacto:
- Caroline Merck, MS
- Número de teléfono: 312-227-2469
- Correo electrónico: cmerck@luriechildrens.org
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Parent or guardian must be an adult (≥18 years of age) and able to understand and provide informed consent.
- Age: Term infants (≥37 weeks) aged 4 months to 24 months at recruitment.
- Admitted to Lurie Children's Hospital or presenting to ED for an acute viral lower respiratory tract infection within 1-3 days of onset.
Exclusion Criteria:
- Inability or unwillingness of a parent or guardian to give written informed consent or comply with study protocol
- Parents who will not include either a puree or some form of bottle feeding such that the infant would be able to take the investigational product in a puree or a liquid (expressed breast milk, supplemental formula, or a small amount of water)
- Currently on a soy based formula as determined by the judgement of the study investigators
- Breastfeeding mothers who are taking soy supplements or soy enriched foods more than 2 times a week and will not stop this level of ingestion while breastfeeding (assessed by soy intake questionnaire). Note there is no coercion to change dietary practices. This is simply an exclusion criteria if the mother does not want to limit soy intake to this level for the time of the study.
- On provider prescribed treatment for recurrent wheezing such as regular or intermittent inhaled steroids
- The infant may not have the following specific contraindications: known congenital thyroid disease, or a history of estrogen sensitive clinically relevant mutations in the family (such as BRCA1).
Medication use:
- Maternal use of tamoxifen during pregnancy or breastfeeding
- Use of immunomodulatory medications such as methotrexate, mycophenolate, azathioprine, or other immunomodulatory agent in the mother if breastfeeding or in the infant.
- Use of another investigational agent in the last 30 days prior
- Current parent reported diagnosis of mental illness or current self-reported drug or alcohol abuse (in the primary caregiver) that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements
- Known allergy to soy protein (either by reported allergy or prior positive allergy results and no history of ongoing ingestion) or reported allergy to NovaSoyTM, from which the investigational product is compounded.
- The infant is currently participating in another allergic disease (asthma, food allergy, or AD) -related pharmaceutical study or intervention study or who have participated in another asthma-related pharmaceutical study or intervention study in the month prior to enrollment
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
- Any chronic condition requiring use of systemic corticosteroids or another immunomodulating agent prior to visit 1 (V1).
Non-adherence:
- Inability / unwillingness of the parents to facilitate ingestion of the investigational product
- Unwillingness of the parents to allow the staff to perform baseline procedures of nasal swabs
- Participant is in foster care or is a ward of the state.
- Caregiver does not have access to a phone (needed for scheduling appointments or responding to questionnaires)
- Plan(s) for the family to move from the area during the study period
- The infant's caretaker does not primarily speak English or Spanish.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: soy isoflavone
soy isoflavone at 1.5 mg/kg divided bid dosed from presentation for 2 - 3 day sof dosing
|
Soy isoflavone will be administered orally at a dose of 1.5 mg/ kg divided bid from presentation to day 7 of illness
|
|
Sin intervención: observational arm for more severe subjects
these subjects will have endotyping carried out by nasal swab at presentation and day 7
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Eos3 transcriptional module expression
Periodo de tiempo: on day 4-7 of illness after 2-3 days of dosing
|
The mean expression level of the Th2 and ciliated epithelium (eos3) transcriptional module at day 4-7 of viral illness
|
on day 4-7 of illness after 2-3 days of dosing
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Th2 and epithelial module expression
Periodo de tiempo: day 4-7 of illness
|
This will include the mean expression level of other key transcriptional modules representing Th2 and epithelial processes, including expression of m24<squamous epithelium>, squa1 <tight junctions and epithelial integrity>, and m27 <TGFB/SMAD3 regulation of PAI-1> modules at day 4-7 of viral illness of viral illness
|
day 4-7 of illness
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Rajesh Kumar, MD, MSCI, Ann & Robert H Lurie Children's hospital of Chicago
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de octubre de 2026
Finalización primaria (Estimado)
31 de diciembre de 2027
Finalización del estudio (Estimado)
30 de junio de 2028
Fechas de registro del estudio
Enviado por primera vez
14 de septiembre de 2026
Primero enviado que cumplió con los criterios de control de calidad
14 de septiembre de 2026
Publicado por primera vez (Actual)
18 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
14 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY00001088 (University of Texas Health Science Center at San Antonio)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Data will be available on request after publication.
Marco de tiempo para compartir IPD
de-identified data will be available after study close.
Criterios de acceso compartido de IPD
all investigators who request access after publication of findings will have a deidentified dataset shared with them
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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