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

• Status: Not yet recruiting
• Trial end date: 2028-09-30
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rajesh Kumar
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); Northwestern University; University of Colorado, Denver; University of South Florida

Criteria

Inclusion Criteria:

1. Parent guardian must be able to understand and provide informed consent.

2. Age: Term children (≥37 weeks gestational age) born from January 1 to May 15 of the recruitment year.

3. High risk of asthma: As determined by one or more of the following:

1. A history of uni- or bi-parental asthma with onset in childhood by parent self report, OR

2. 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

3. atopic dermatitis in the child determined by parent report of a physician diagnosis

4. Genotype: Either homozygous or heterozygous for the PAI-1 risk allele (i.e. 4G4G or 4G5G).

Exclusion Criteria:

1. Inability or unwillingness of a parent guardian to give written informed consent or comply with study protocol.

2. 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).

3. Currently on a soy based formula.

4. 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.

5. On treatment for recurrent wheezing such as regular inhaled steroids.

6. The subject 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 BRACA1).

7. Medication use

1. Maternal use of tamoxifen in pregnancy or if breastfeeding

2. Use of immunomodulatory medications such at methotrexate, mycophenolate, azathioprine, or other immunomodulatory agent in the mother if breastfeeding or in the infant.

8. Use of another investigational agent in the last 30 days prior to randomization.

9. 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.

10. 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.

11. 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.

12. 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.

13. Any chronic condition requiring use of systemic corticosteroids or another immunomodulating agent at screening or run-in, and during the course of the study

14. Non-adherence:

1. Inability / unwillingness of the parents to induce the child to swallow study medication

2. Unwillingness of the parents to allow the staff to perform baseline measurements

15. Living with a foster parent as a ward of the state.

16. Caregiver does not have access to a phone (needed for scheduling appointments or responding to questionnaires);

17. Plan(s) for the family to move from the area during the study period;

18. The participant's caretaker does not primarily speak English or Spanish