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

NCT05667701 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: CAUSE-LCH-001U01AI160018-01
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to compare soy isoflavones to placebo in children who at risk of asthma and have a genetic variation which results in them making more of a pro-inflammatory protein, plasminogen activator inhibitor-1. The main questions this trail seeks to answer is: will soy isoflavones decrease the proportion of infants with aT2 high endotype at the end of treatment, and secondarily decrease the number of wheezing episodes in these children when given in the first year of life. Participants will be asked to ingest soy isoflavone or placebo twice daily mixed into a liquid or puree vehicle for 7 months from randomization. There will be 3 mandatory in-person visits, and 6 virtual visits in the first year. There will also be 11 monthly questionnaires and 1 in person visit in the observation year. Participants will have 4 nasal swabs, 3 blood draws, and also provide 4 stool samples over the course of the study.

Conditions

Wheezing; Asthma in Children

Keywords

wheezing; soy isoflavone; PAI-1

Outcome Measures

Primary Outcomes (1)

• T2 endotype

  This measure is determined by the proportion of subjects designated as having a T2 high endotype at the end of the treatment period (week 32) in the soy genistein vs placebo treatment arms.

  From week 0 (randomization) to week 30 (end of treatment)

Secondary Outcomes (3)

• wheezing episodes

  7 months

• Expiratory variability index

  from week 0 (randomization) to week 30 (end of treatment) and from week 0 (randomization) to week 88 (end of study)

• safety and tolerability

  from week 0 (randomization) to week 88 (end of study)

Other Outcomes (4)

• Other measures of wheezing and respiratory morbidity

  week 88 - end of study visit

• sensitization to allergens

  Week 30 at the end of treatment

• work disruption due to child's asthma

  Week 0 to week 30

Study Arms (2)

Soy isoflavone

EXPERIMENTAL

Soy isoflavone powder dosed in puree or liquid twice daily

Drug: Soy isoflavone

Placebo

PLACEBO COMPARATOR

Matching placebo powder dosed in puree or liquid twice daily

Drug: matching placebo

Interventions

Soy isoflavone DRUG

Soy isoflavone supplement (Novasoy) that contains isoflavones (genistein, daidzein, glycetein) given at a dose of genistein aglycone equivalents to provide the genistein dosing of 22.6 mg/day for children aged 2-10 months, and 30.3 mg/day children aged 10-24 months

Also known as: Novasoy

Soy isoflavone

matching placebo DRUG

A matching placebo also administered twice daily.

Also known as: placebo

Placebo

Eligibility Criteria

• Age: 2 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Parent/guardian must be an adult (≥18 years of age) and able to understand and provide informed consent.
• Age: Term infants (≥37 weeks gestational age) less than 12 months of age at recruitment
• High risk of asthma: As determined by one or more of the following:
• A history of uni- or bi-parental asthma with onset in childhood by parent self report, OR
• Uni- or bi-parental asthma with onset after childhood along with the presence of one or more other comorbid atopic condition including allergic rhinitis, atopic dermatitis, or food allergy, OR
• atopic dermatitis in the child determined by parent report of a physician diagnosis
• Genotype: Either homozygous or heterozygous for the PAI-1 risk allele (i.e. 4G4G or 4G5G).
• Have a primary place of residence in one of the pre-selected recruitment census tracts as outlined in the SIRA Manual of Operations (MOP).

You may not qualify if:

• \. 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.
• 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.
• On treatment for recurrent wheezing such as regular 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 in pregnancy or if breastfeeding
• Use of immunomodulatory medications such at 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 to randomization.
• Current, parent reported, diagnosis of mental illness or current, diagnosed or 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 skin testing to soy prior to randomization) or reported allergy to NovaSoy, from which the investigational product is compounded.
• The infant is currently participating in another asthma-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.
• Infant requiring intubation prior to screening.

Sponsors & Collaborators

• Rajesh Kumar: lead
• Northwestern University: collaborator
• University of South Florida: collaborator
• University of Colorado, Denver: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (2)

Ann and Robert H Lurie Childrens Hospital of Chicago

Chicago, Illinois, 60611, United States

RECRUITING

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Respiratory Sounds

Interventions

Soybean Proteins

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food and Beverages

Study Officials

• Rajesh Kumar, MD

  Ann and Robert H. Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Godley, RN

CONTACT

312 227 6010; sgodley@luriechildrens.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Neither participants nor the clinical center investigators will be informed of the treatment group assignment to maintain the mask. The randomization sequence will be generated by the study statistician and uploaded to the REDCap database, and randomization will be implemented through REDCap. Only the treatment distribution center (study pharmacist) and the independent unblinded study statistician will have access to the actual treatment assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Pediatrics

Model Details: genotype stratified, quadruple blinded randomized clinical trial

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: December 29, 2022
• Study Start: September 18, 2024
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The investigators anticipate that data will be made publicly available 3 years after completion of the study.
• Access Criteria: Investigators will be able to apply for use of the data and this will be reviewed by a committee, to prevent duplicative efforts.

Locations

US (2)