Status:
RECRUITING
A Clinical Trial of Soluble Fiber for Asthma
Lead Sponsor:
Phoenix Children's Hospital
Collaborating Sponsors:
Northern Arizona University
National Institute on Minority Health and Health Disparities (NIMHD)
Conditions:
Asthma in Children
Eligibility:
All Genders
6-17 years
Phase:
PHASE2
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...
Detailed Description
A Phase II randomized, controlled, clinical trial analyzing the impact of increasing fiber intake and the gut microbiome for children with asthma. If eligible, (determined by inclusions/exclusion crit...
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
Key Trial Info
Start Date :
November 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2027
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT06372249
Start Date
November 10 2025
End Date
May 31 2027
Last Update
March 4 2026
Active Locations (1)
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1
Phoenix Children's
Phoenix, Arizona, United States, 85016