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Isoflavones

Soy isoflavone for Wheezing (SIRA Trial)

Phase 2

Recruiting

Led By Rajesh Kumar, MD

Research Sponsored by Rajesh Kumar

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 months

Awards & highlights

SIRA Trial Summary

"This trial aims to see if giving soy isoflavones to children at risk of asthma and with a specific genetic variation can reduce wheezing episodes in the first year of life. Participants will take

Who is the study for?

This trial is for full-term infants born within specific dates, who are at risk for asthma and have a genetic variation linked to inflammation. They must have a family history of asthma or related conditions, or the child must have been diagnosed with atopic dermatitis. Parents need to consent and participate in several visits and tests.Check my eligibility

What is being tested?

The study compares soy isoflavones with a placebo in preventing wheezing in high-risk infants during their first year. Infants will take the treatment twice daily for 7 months, attend physical and virtual check-ups, answer monthly questionnaires, and provide nasal swabs, blood samples, and stool samples.See study design

What are the potential side effects?

While not explicitly listed here, potential side effects from soy isoflavones could include mild digestive issues or allergic reactions; however these are generally considered safe especially when administered as part of a clinical trial under medical supervision.

SIRA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

wheezing episodes

Secondary outcome measures

Expiratory variability index

safety and tolerability

Other outcome measures

Daycare/ pre-school Absences due to the child's asthma

Other measures of wheezing and respiratory morbidity

sensitization to allergens

+1 more

SIRA Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Soy isoflavoneExperimental Treatment1 Intervention

Soy isoflavone powder dosed in puree or liquid twice daily

Group II: PlaceboPlacebo Group2 Interventions

Matching placebo powder dosed in puree or liquid twice daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Soy isoflavone

2013

Completed Phase 1

~70

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Northwestern UniversityOTHER

1,591 Previous Clinical Trials

917,518 Total Patients Enrolled

National Institute of Allergy and Infectious Diseases (NIAID)NIH

3,270 Previous Clinical Trials

5,485,093 Total Patients Enrolled

1 Trials studying Wheezing

192 Patients Enrolled for Wheezing

University of Colorado, DenverOTHER

1,739 Previous Clinical Trials

2,150,001 Total Patients Enrolled

1 Trials studying Wheezing

192 Patients Enrolled for Wheezing

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the clinical trial considering participants who are younger than 75 years old?

"Eligible candidates for this research study range between 2 and 6 months old. Out of the total studies available, there are 146 focused on subjects under 18 years old and 210 tailored towards individuals aged over 65."

Answered by AI

Has the FDA given its approval for Soy isoflavone?

"Based on our team's evaluation, the safety rating for Soy isoflavone stands at 2 as per the Power scale. This assessment stems from being in a Phase 2 trial where there exists data supporting safety but not efficacy."

Answered by AI

Are individuals currently eligible to apply for participation in this ongoing medical study?

"According to information on clinicaltrials.gov, this research investigation is presently in the process of soliciting prospective participants. The initial posting date for this study was March 15th, 2024, with the most recent update noted as March 29th, 2024."

Answered by AI

Which individuals meet the criteria to participate in this experimental study?

"To be eligible for enrollment in this research, individuals must exhibit wheezing and fall within the age range of 2 to 6 months. The study aims to recruit approximately 144 participants."

Answered by AI

What is the upper limit on the number of individuals involved in this medical study?

"Indeed, details on clinicaltrials.gov reveal that recruitment for this investigation is ongoing. The trial was first listed on March 15th, 2024, and the most recent update occurred on March 29th, 2024. A total of 144 participants are sought from two designated locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Soy Isoflavones For Inner City Infants At Risk For Asthma (SIRA) Study

Rajesh Kumar 2024. "Soy Isoflavones For Inner City Infants At Risk For Asthma (SIRA) Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05667701.