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RecruitingPhase 2NCT06372249

A Clinical Trial of Soluble Fiber for Asthma

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Trial Parameters

ConditionAsthma in Children
SponsorPhoenix Children's Hospital
Study TypeINTERVENTIONAL
PhasePhase 2
Enrollment105
SexALL
Min Age6 Years
Max Age17 Years
Start Date2025-11-10
Completion2027-05-31
Interventions
Inulin

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Brief 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 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

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