Using soluble fiber to improve asthma in children
Official title: A Phase ll Randomized Controlled Trial of Soluble Fiber for Asthma
Run by Phoenix Children's Hospital · NCT06372249 · Data updated 2026-11-12
This study is testing if a soluble fiber supplement can help improve asthma symptoms in children aged 6 to 17.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 6 Years to 17 Years |
| Sex | All |
| Enrollment | 105 (estimated) |
| Sponsor | Phoenix Children's Hospital Academic / other |
| Locations | 1 site (Phoenix, Arizona) |
| Status | Recruiting |
| Started | November 10, 2025 |
| Main results expected | May 31, 2027 |
| Study ends | May 31, 2027 |
| Registry record updated | March 4, 2026 |
| Trial ID | NCT06372249 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 6-17 with a recent asthma diagnosis and specific criteria related to their asthma management.
✕Probably not a fit
Patients with conditions like cystic fibrosis or bronchiectasis, or those with very low baseline fiber intake, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effects of soluble fiber (NOVELOSETM 3490) on asthma symptoms in children aged 6-17. Participants will be randomly assigned to receive either the fiber supplement or a placebo, and their dietary fiber intake will be assessed using a dietary recall questionnaire. Throughout the study, researchers will collect blood serum, fecal samples, and nasal wash to analyze the gut microbiome and its potential connection to asthma. The trial lasts for six weeks, during which participants will receive counseling on dietary implementation and will be compensated for their involvement.
Why it matters
Potential benefit: If successful, this study could lead to dietary interventions that improve asthma control in children.
How similar studies have gone: While the approach of using dietary fiber to manage asthma is innovative, similar studies have shown promise in exploring the gut microbiome's role in respiratory conditions.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Between ages 6-17 * Asthma diagnosis within the last 2 years * Fractional excretion of exhaled nitric oxide (FeNO) \> 50 ppb OR a clinical history of environmental allergies as defined by a positive skin prick or positive specific immunoglobulin E (IgE) tests to aeroallergens * No emergency department visits in the past 1 month * Ability to consume a liquid drink of fiber or placebo * Ability to return for a 4-6 week follow-up visit * No special or unique diet Exclusion Criteria: * Cystic fibrosis * Bronchiectasis * Change in asthma medicines other than short acting bronchodilators planned over the next 4-6 weeks * Baseline estimated daily fiber intake less than or equal to 16 grams as determined by the ASA 24 * Sibling of a participant already enrolled in the study
Where it's running
-
Phoenix Children's
Phoenix, Arizona, United States Recruiting
Study contacts
- Principal investigator: Matthew Rank — Phoenix Children's
- Study coordinator: Daniel Gastaldo
- Email: dgastaldo@phoenixchildrens.com
- Phone: 6029334979
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.