- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07828405
Genes, Soy Isoflavones, and Virus (GSV)
14 de setembro de 2026 atualizado 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Estimado)
60
Estágio
- Fase 2
- Fase 1
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Caroline Merck, MPH
- Número de telefone: 312-227-2469
- E-mail: cmerck@luriechildrens.org
Estude backup de contato
- Nome: Aliviya Schulze, BS
- Número de telefone: 312-227-5391
- E-mail: aschulze@luriechildrens.org
Locais de estudo
-
-
Illinois
-
Chicago, Illinois, Estados Unidos, 60311
- Ann & Robert H Lurie Children's hospital of Chicago
-
Contato:
- Aliviya Schulze, BS
- Número de telefone: 312-227-5391
- E-mail: aschulze@luriechildrens.org
-
Contato:
- Caroline Merck, MS
- Número de telefone: 312-227-2469
- E-mail: cmerck@luriechildrens.org
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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
|
|
Sem intervenção: observational arm for more severe subjects
these subjects will have endotyping carried out by nasal swab at presentation and day 7
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Eos3 transcriptional module expression
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Th2 and epithelial module expression
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Rajesh Kumar, MD, MSCI, Ann & Robert H Lurie Children's hospital of Chicago
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de outubro de 2026
Conclusão Primária (Estimado)
31 de dezembro de 2027
Conclusão do estudo (Estimado)
30 de junho de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
14 de setembro de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
14 de setembro de 2026
Primeira postagem (Real)
18 de setembro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
18 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
14 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- STUDY00001088 (University of Texas Health Science Center at San Antonio)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
Data will be available on request after publication.
Prazo de Compartilhamento de IPD
de-identified data will be available after study close.
Critérios de acesso de compartilhamento IPD
all investigators who request access after publication of findings will have a deidentified dataset shared with them
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .