Actively Recruiting
A Phase II Randomized Controlled Trial of Soluble Fiber (Fruitafit Inulin) for Asthma in Children
Led by Phoenix Children's Hospital · Updated on 2026-03-04
105
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
P
Phoenix Children's Hospital
Lead Sponsor
N
Northern Arizona University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of increasing soluble fiber intake on the gut microbiome in children aged 6 to 17 with asthma. This Phase II randomized controlled trial aims to understand how diet, specifically fiber intake, may influence asthma symptoms and related biological pathways. Participants will be assessed through dietary recalls and various biological samples to explore connections between diet and asthma control. Participants will be randomly assigned to receive either soluble fiber (Fruitafit Inulin) or a placebo (Maltodextrin). After initial assessments including dietary recall, nasal wash, blood samples, and an asthma control questionnaire, participants will receive counseling on how to include the study product in their diet. Over approximately 30 days, participants will collect and submit three stool samples for microbiome and metabolomic analysis, and repeat assessments at a second visit about 25 days later. Throughout the study, participants will complete questionnaires, provide biological samples including blood, nasal wash, and stool, and undergo dietary intake assessments. Researchers will monitor gut microbiome diversity, asthma control, nasal inflammation, and circulating short-chain fatty acids. The study includes safety monitoring for minimal risks such as discomfort from sample collection and blood draws. Participants receive compensation and partial dietary results, with total involvement lasting about one month.
CONDITIONS
Brief Title
A Clinical Trial of Soluble Fiber for Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between ages 6 and 17 years
- Asthma diagnosis within the last 2 years
- Fractional excretion of exhaled nitric oxide (FeNO) greater than 50 ppb OR a history of environmental allergies confirmed by skin prick or IgE tests
- No emergency department visits for asthma in the past 1 month
- Ability to consume a liquid drink containing fiber or placebo
- Ability to return for a 4-6 week follow-up visit
- No special or unique diet
You will not qualify if you...
- Diagnosis of cystic fibrosis
- Diagnosis of bronchiectasis
- Planned change in asthma medicines other than short acting bronchodilators over the next 4-6 weeks
- Baseline estimated daily fiber intake less than or equal to 16 grams as determined by dietary recall
- Sibling of a participant already enrolled in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) to complete dietary recall questionnaire and eligibility assessment
Duration - Approximately 30 days
Participants take either soluble fiber (Fruitafit Inulin) or placebo and complete questionnaires. They collect and send stool samples for microbiome analysis.
2 in-person visits; stool samples collected at home and mailed at specified times
Trial Site Locations
Total: 1 location
1
Phoenix Children's
Phoenix, Arizona, United States, 85016
Actively Recruiting
Research Team
D
Daniel Gastaldo
M
Matthew Rank
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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