Genes, Soy Isoflavones, and Virus
ConditionWheezing
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age4-24
SponsorAnn & Robert H Lurie Children's Hospital of Chicago
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Soy Isoflavone Nutritional Supplements
DrugSoy isoflavone will be administered orally at a dose of 1.5 mg/ kg divided bid from presentation to day 7 of illness
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: soy isoflavoneExperimental treatment 1 intervention
Group B: observational arm for more severe subjectsNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Eos3 transcriptional module expression
The mean expression level of the Th2 and ciliated epithelium (eos3) transcriptional module at day 4-7 of viral illness
Time frame
on day 4-7 of illness after 2-3 days of dosingSecondary outcomes
1
Th2 and epithelial module expression
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
Time frame
day 4-7 of illnessSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: