Soluble Corn Fiber Supplementation for Asthma

NCT03673618 | Completed Phase 2

• 1 other identifier: Phoenixchildrens-18-121
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (1)

• Asthma symptoms

  Asthma Control Questionnaire

  4 weeks

Secondary Outcomes (4)

• 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

Study Arms (2)

PROMOTIR soluble corn fiber

EXPERIMENTAL

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

Malodextrin

PLACEBO COMPARATOR

Participants will ingest malodextrin in a fruit-flavored beverage for 4 weeks alongside their normal diet and normal asthma treatments.

Drug: Soluble Corn Fiber

Interventions

Soluble Corn Fiber DRUG

Fiber or placebo

Malodextrin; PROMOTIR soluble corn fiber

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Cystic fibrosis
• Bronchiectasis
• Change in asthma medicines other than short acting bronchodilators planned over the next 4-6 weeks.

Sponsors & Collaborators

• Phoenix Children's Hospital: lead
• Northern Arizona University: collaborator
• Flinn Foundation: collaborator
• Mayo Clinic: collaborator

Study Sites (1)

Phoenix Childrens Hospital

Phoenix, Arizona, 85016, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A study pharmacist will provide soluble corn fiber or a placebo (malodextrin) in identical packets to be dispensed in identical fruit-flavored beverage
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: September 17, 2018
• Study Start: September 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 31, 2023

Record last verified: 2022-04

Locations

US (1)