Soy Isoflavones for Wheezing

(GSV Trial)

CM
AS
Overseen ByAliviya Schulze, BS
Age: < 18
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

RK

Rajesh Kumar, MD, MSCI

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Are You a Good Fit for This Trial?

This trial is for children who do not have a diagnosis of asthma but may be at risk. It focuses on those with or without a specific variation in the PAI-1 gene and who experience acute respiratory illnesses.

Inclusion Criteria

My parent or guardian is at least 18 and can give informed consent.
My child was born full-term and is between 4 and 24 months old.
I was admitted or came to the ER for a viral lung infection within the last 3 days.

Exclusion Criteria

Currently on a soy based formula as determined by the judgement of the study investigators
I have not used any experimental drugs in the past 30 days.
Participant is in foster care or a ward of the state
See 17 more

What Are the Treatments Tested in This Trial?

Interventions

  • Soy Isoflavone Nutritional Supplements

Trial Overview

The study tests whether giving soy isoflavone supplements to children during an acute respiratory illness can reduce airway inflammation, especially in those with a certain PAI-1 gene variation. The effects are compared between groups.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: soy isoflavoneExperimental Treatment1 Intervention
Group II: observational arm for more severe subjectsActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ann & Robert H Lurie Children's Hospital of Chicago

Lead Sponsor

Trials
275
Recruited
5,182,000+