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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: Recruiting Phase 2 study of Asthma in Children and Wheezing, sponsored by Rajesh Kumar.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What NCT05667701 shows while recruiting
NCT05667701 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 204-participant average among 44 other Asthma in Children trials with a reported enrollment target (68% lower).
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 a single indexed study location in 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.
Where NCT05667701's enrollment target sits among peer trials
65 28th of 44 higher than 17 of 44 other Asthma in Children trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma in Children trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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