Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05667701 · ClinicalTrials.gov registry record · Phase 2
Soy Isoflavones For Inner City Infants At Risk For Asthma (SIRA) Study
A Phase 2 study of Asthma in Children and Wheezing, sponsored by Rajesh Kumar.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 65
- Enrollment target
- 2
- Study locations
NCT05667701 is a Phase 2 study of Asthma in Children and Wheezing that is actively recruiting participants, run by Rajesh Kumar. The registered enrollment target is 65 participants, below the 204-participant average among 44 other Asthma in Children trials with a reported enrollment target (68% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT05667701, a Phase 2 study of Asthma in Children and Wheezing, is actively recruiting participants, sponsored by Rajesh Kumar.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 65 participants
- Enrollment target
- 2
- Study locations
Study 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 Studied
Interventions
- DRUG Soy isoflavone
- DRUG matching placebo
Study Locations (2)
Illinois
- Ann and Robert H Lurie Childrens Hospital of Chicago - Chicago
- Northwestern University Feinberg School of Medicine - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2024-09-18 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05667701
The ClinicalTrials.gov registry entry for NCT05667701 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 204-participant average among 44 other Asthma in Children trials with a reported enrollment target (68% lower). The listed sponsor is Rajesh Kumar, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Asthma in Children appearing as the primary indexed condition, and to 2 interventions - of which Soy isoflavone is the first listed.
NCT05667701 reports 2 study locations spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT05667701 about?
NCT05667701 is a clinical study titled "Soy Isoflavones For Inner City Infants At Risk For Asthma (SIRA) Study". 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 isofl...
What is the current status of trial NCT05667701?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2024-09-18. Estimated completion is 2028-12-31.
What conditions does trial NCT05667701 study?
This clinical trial studies the following conditions: Asthma in Children, Wheezing.
What interventions are being tested in trial NCT05667701?
The interventions under investigation include: Soy isoflavone (DRUG), matching placebo (DRUG).
Who is sponsoring clinical trial NCT05667701?
This trial is sponsored by Rajesh Kumar, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05667701 being conducted?
This trial has 2 study locations across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Asthma in Children
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Omalizumab Before Onset of Exacerbations
RECRUITING · Phase 2
-
A Clinical Trial of Soluble Fiber for Asthma
RECRUITING · Phase 2
-
Action Towards Health Equity and Improved Air Quality in the Duwamish Valley: A Multilevel Asthma Intervention
RECRUITING · NA
-
SMART Implementation-Effectiveness Trial 1
RECRUITING · NA
-
Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)
RECRUITING · NA
-
Wearable Electronic Breath Sound Sensing Device
RECRUITING
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.