Soluble Fiber for Asthma in Children

This study is looking at how a soluble fiber called inulin (Fruitafit Inulin) might affect asthma in children aged 6 to 17. You might be able to join if you have an asthma diagnosis from the last two years and either a high FeNO (fractional exhaled nitric oxide, a measure of airway inflammation) or a history of environmental allergies. The study wants to see if increasing fiber intake can change the types of microbes in your gut and potentially improve asthma. Success in this study will be measured by changes in "alpha diversity," which refers to the variety of bacteria in your gut, after 6 weeks. The current recruitment status is unclear.

Study design
This is a randomized controlled trial, meaning participants will be randomly assigned to receive either inulin or a placebo. The study plans to enroll 105 children.
What's involved
You would complete a diet questionnaire, have a nasal wash, and have your blood drawn. You'll also provide three stool samples over approximately 30 days and have a second study visit.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 6 weeks, and the total study time is approximately 30 days.

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NCT06372249

A Clinical Trial of Soluble Fiber for Asthma

Recruiting
PHASE2Ages 6–17InterventionalTreatment
Phoenix Children's Hospital
~105 participants
Updated 2026-03-04 on ClinicalTrials.gov
What's tested:Inulin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Alpha diversity.
Measured over 6 weeks
Asthma in Children
1 sites across 1 states
Arizona1
  • Matthew Rank · PRINCIPAL_INVESTIGATOR · Phoenix Children's

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Eligibility criteria

Inclusion

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

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
  • Alpha diversity.6 weeks

    A total of 84 participants is required to find significant difference of 54 units of Richness at 90% power with a small effect size. Alpha diversity is used to measure the abundance that individual microbes can be observed. Statistical analysis is used to generate the significance of stool sample diversity as well as how many participants are needed to see the marker.