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).

Study Overview

• Status: Completed
• Conditions: Asthma in Children
• Intervention / Treatment: Drug: Soluble Corn Fiber

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Matthew A Rank, MD; Phone Number: 480-301-4284; Email: rank.matthew@mayo.edu
• Study Contact Backup: Name: James Woodward, MD; Phone Number: 602-933-5437; Email: jwoodward@phoenixchildrens.com

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Phoenix Childrens Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PROMOTIR soluble corn fiber; 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; Fiber or placebo
Placebo Comparator: Malodextrin; Participants will ingest malodextrin in a fruit-flavored beverage for 4 weeks alongside their normal diet and normal asthma treatments.	Drug: Soluble Corn Fiber; Fiber or placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Phoenix Children's Hospital
• Collaborators: Mayo Clinic; Northern Arizona University; Flinn Foundation

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: September 12, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: Phoenixchildrens-18-121

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No