Soluble Corn Fiber Supplementation for Asthma

• ClinicalTrials.gov Identifier: NCT03673618
• Recruitment Status: Unknown
• First Posted: September 17, 2018
• Last Update Posted: August 28, 2019
• Sponsor: Phoenix Children's Hospital
• Collaborators: Northern Arizona University; Flinn Foundation; Mayo Clinic
• Information provided by (Responsible Party): Phoenix Children's Hospital

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Asthma in Children	Drug: Soluble Corn Fiber	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: A study pharmacist will provide soluble corn fiber or a placebo (malodextrin) in identical packets to be dispensed in identical fruit-flavored beverage
• Primary Purpose: Treatment
• Official Title: Soluble Corn Fiber Supplementation for Asthma
• Estimated Study Start Date: August 28, 2019
• Estimated Primary Completion Date: January 1, 2020
• Estimated Study Completion Date: June 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Asthma symptoms [ Time Frame: 4 weeks ]
   Asthma Control Questionnaire

Secondary Outcome Measures :

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 ]

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Contacts

Contact: Matthew A Rank, MD; 480-301-4284; rank.matthew@mayo.edu

Contact: James Woodward, MD; 602-933-5437; jwoodward@phoenixchildrens.com

Sponsors and Collaborators

Phoenix Children's Hospital

Northern Arizona University

Flinn Foundation

Mayo Clinic

More Information

• Responsible Party: Phoenix Children's Hospital
• ClinicalTrials.gov Identifier: NCT03673618
• Other Study ID Numbers: Phoenixchildrens-18-121
• First Posted: September 17, 2018
• Last Update Posted: August 28, 2019
• Last Verified: August 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases