What is Fruitafit Inulin studying for asthma in children?

This trial is studying how increasing soluble fiber intake with Fruitafit Inulin affects the gut microbiome and asthma control in children. Researchers want to understand if diet changes can improve asthma symptoms by influencing gut microbes. The study is sponsored by Phoenix Children's Hospital.

Who may be eligible for this asthma clinical trial?

Children aged 6 to 17 with a recent asthma diagnosis and evidence of airway inflammation or environmental allergies may be eligible. Participants must be able to consume the study drink and attend follow-up visits. Please review eligibility criteria for more details.

Is there any cost to participate in this asthma clinical trial?

Study-related care, including the study drug or placebo and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 2

Age: 6Years - 17Years

All Genders

ID06372249

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

Research Sites

N/A

Total Duration

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

Age: 6Years - 17Years

All Genders

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

Research Team

Daniel Gastaldo

Matthew Rank

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