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Completed

NCT Number: NCT03673618

Soluble Corn Fiber Supplementation for Asthma

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).

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Key information

Conditions

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Phoenix Childrens Hospital

Phoenix, Arizona, 85016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Soluble Corn Fiber

Drug

Fiber or placebo

Primary outcomes

  1. Asthma symptoms

    Time frame: 4 weeks

    Asthma Control Questionnaire

Secondary outcomes

  1. Change in Serum Short Chain Fatty Acids

    Time frame: Before treatment period and after treatment for 4 weeks

  2. Change in nasal wash Th2 gene expression

    Time frame: Before treatment period and after treatment for 4 weeks

  3. Alpha and beta diversity in participants' nasal microbiome

    Time frame: Before treatment period and after treatment for 4 weeks

  4. Alpha and beta diversity in participants' stool microbiome

    Time frame: Before treatment period and after treatment for 4 weeks

Sponsors and collaborators

Lead sponsor

Phoenix Children's Hospital

Other

Collaborators

  • Flinn Foundation
  • Mayo Clinic
  • Northern Arizona University

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 17, 2018
Registry last updated
Mar 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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