Soluble Corn Fiber Supplementation for Asthma

Study Overview
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Brief Summary
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Studies of the importance of the human microbiome have demonstrated that microbial metabolites of fermentation of our dietary products (e.g. dietary fiber) have a multitude of health benefits. The investigators aim to determine whether supplementation of asthmatic children with soluble corn fiber alongside standard of care reduces airway inflammation driven by the gut microbial metabolites acetate, propionate, or butyrate (short chain fatty acids).

Detailed Description
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Asthma is a complex inflammatory disease of the airways that is estimated to affect 300 million people worldwide. Incidence of asthma is steadily increasing in Western populations; an additional 100 million asthma diagnoses are anticipated by the year 2025. Asthma is a multifactorial disease affected by genetic and environmental factors. One major and potentially modifiable environmental factor is the Western diet. The Western diet influences the microbiome, which in turn, may influence inflammatory airway diseases via a gut microbiome-airway connection. The investigators hypothesize that prebiotic dietary fiber supplementation leads to increased circulating short chain fatty acid production and improvement in asthma disease activity. The investigators will recruit 20 children, ages 6-17 years old, with asthma from the Severe Asthma Clinic or General Pulmonary Clinic at Phoenix Children's Hospital. Participants will be randomly assigned (1:1) using a random number generator to ingest PROMOTIR soluble corn fiber (85% fiber, 12 g/day) in a fruit-flavored beverage or placebo (malodextrin in a similar fruit-flavored beverage) as previously described. Participants will be asked to consume the prebiotic soluble corn fiber (or placebo) for 4 weeks alongside their normal diet and normal asthma treatments. Blood will be collected pre- and post-fiber intervention to measure baseline and post-intervention circulating SCFAs. Stool samples and nasal wash will be collected for microbiome and immune analysis pre- and post- fiber consumption. Nasal washes will be collected pre- and post-fiber consumption to measure inflammatory patterns.

Official Title
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Soluble Corn Fiber Supplementation for Asthma

Conditions
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Asthma in Children

Intervention / Treatment
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* Drug: Soluble Corn Fiber


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of asthma Fractional excretion of exhaled nitric oxide (FeNO) > 50 ppb OR a history of environmental allergies No emergency department or hospital visits for asthma in the past 3 months No systemic corticosteroids in the past 1 month Ability to consume a liquid drink of SCF or placebo Ability to return for a 4-6 week follow-up visit No special or unique diet as determined by PI/CO-Is. Exclusion Criteria: Cystic fibrosis Bronchiectasis Change in asthma medicines other than short acting bronchodilators planned over the next 4-6 weeks.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PROMOTIR soluble corn fiber<br>Participants will ingest PROMOTIR soluble corn fiber (85% fiber, 12 g/day) in a fruit-flavored beverage for 4 weeks alongside their normal diet and normal asthma treatments. | Drug: Soluble Corn Fiber<br>* Fiber or placebo<br>|
| Placebo Comparator: Malodextrin<br>Participants will ingest malodextrin in a fruit-flavored beverage for 4 weeks alongside their normal diet and normal asthma treatments. | Drug: Soluble Corn Fiber<br>* Fiber or placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma symptoms | Asthma Control Questionnaire | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Serum Short Chain Fatty Acids |  | Before treatment period and after treatment for 4 weeks | 
| Change in nasal wash Th2 gene expression |  | Before treatment period and after treatment for 4 weeks | 
| Alpha and beta diversity in participants' nasal microbiome |  | Before treatment period and after treatment for 4 weeks | 
| Alpha and beta diversity in participants' stool microbiome |  | Before treatment period and after treatment for 4 weeks |