A Clinical Trial of Soluble Fiber for Asthma

Description

Randomized controlled trial of soluble fiber (NOVELOSETM 3490). Participants will complete an ASA 24 dietary recall questionnaire to access their fiber intake. If eligible for the study, participants will be supplemented to their target fiber dosage with either soluble fiber (NOVELOSETM 3490) or placebo. Collection of blood serum, fecal samples, and nasal wash will aid in analyzing the microbes present in one's gut and how fiber and diet may impact it. Thus, allowing researchers to better understand the pathways that may connect diet and asthma and if it is possible to improve asthma by altering one's diet.

Conditions

Asthma in Children

Talk to us

Study Overview

On this page

Study Details

Study overview

Randomized controlled trial of soluble fiber (NOVELOSETM 3490). Participants will complete an ASA 24 dietary recall questionnaire to access their fiber intake. If eligible for the study, participants will be supplemented to their target fiber dosage with either soluble fiber (NOVELOSETM 3490) or placebo. Collection of blood serum, fecal samples, and nasal wash will aid in analyzing the microbes present in one's gut and how fiber and diet may impact it. Thus, allowing researchers to better understand the pathways that may connect diet and asthma and if it is possible to improve asthma by altering one's diet.

A Phase ll Randomized Controlled Trial of Soluble Fiber for Asthma

A Clinical Trial of Soluble Fiber for Asthma

Condition
Asthma in Children
Intervention / Treatment

-

Contacts and Locations

Phoenix

Phoenix Children's, Phoenix, Arizona, United States, 85016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Between ages 6-17
  • * Asthma diagnosis within the last 2 years
  • * Fractional excretion of exhaled nitric oxide (FeNO) \> 50 ppb OR a clinical history of environmental allergies as defined by a positive skin prick or positive specific immunoglobulin E (IgE) tests to aeroallergens
  • * No emergency department visits in the past 1 month
  • * Ability to consume a liquid drink of fiber or placebo
  • * Ability to return for a 4-6 week follow-up visit
  • * No special or unique diet
  • * Cystic fibrosis
  • * Bronchiectasis
  • * Change in asthma medicines other than short acting bronchodilators planned over the next 4-6 weeks
  • * Baseline estimated daily fiber intake less than or equal to 16 grams as determined by the ASA 24
  • * Sibling of a participant already enrolled in the study

Ages Eligible for Study

6 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Phoenix Children's Hospital,

Matthew Rank, PRINCIPAL_INVESTIGATOR, Phoenix Children's

Study Record Dates

2027-04