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A Clinical Trial of Soluble Fiber for Asthma

RECRUITINGPhase 2Sponsored by Phoenix Children's Hospital
Actively Recruiting
PhasePhase 2
SponsorPhoenix Children's Hospital
Started2025-11-10
Est. completion2027-05-31
Eligibility
Age6 Years – 17 Years
Healthy vol.Accepted
Locations1 site

Summary

Randomized controlled trial of soluble fiber (Fruitafit Inulin). Participants will complete an ASA 24 dietary recall questionnaire to access their fiber intake. If eligible for the study, participants will be supplemented to their target fiber dosage with either soluble fiber (Fruitafit Inulin) or placebo. Collection of blood serum, fecal samples, and nasal wash will aid in analyzing the microbes present in one's gut and how fiber and diet may impact it. Thus, allowing researchers to better understand the pathways that may connect diet and asthma and if it is possible to improve asthma by altering one's diet.

Eligibility

Age: 6 Years – 17 YearsHealthy volunteers accepted
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

Conditions2

AsthmaAsthma in Children

Interventions1

Locations1 site

Phoenix Children's
Phoenix, Arizona, 85016
Daniel Gastaldo602-933-4979dgastaldo@phoenixchildrens.com

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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