NOT_YET_RECRUITING

A Clinical Trial of Soluble Fiber for Asthma

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

A Phase ll Randomized Controlled Trial of Soluble Fiber for Asthma

Quick Facts

Study Start:2025-06
Study Completion:2027-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:NOT_YET_RECRUITING

Study ID

NCT06372249

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.

Ages Eligible for Study:6 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Between ages 6-17
  2. * Asthma diagnosis within the last 2 years
  3. * 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
  4. * No emergency department visits in the past 1 month
  5. * Ability to consume a liquid drink of fiber or placebo
  6. * Ability to return for a 4-6 week follow-up visit
  7. * No special or unique diet
  1. * Cystic fibrosis
  2. * Bronchiectasis
  3. * Change in asthma medicines other than short acting bronchodilators planned over the next 4-6 weeks
  4. * Baseline estimated daily fiber intake less than or equal to 16 grams as determined by the ASA 24
  5. * Sibling of a participant already enrolled in the study

Contacts and Locations

Study Contact

Daniel Gastaldo
CONTACT
6029334979
dgastaldo@phoenixchildrens.com
Matthew Rank
CONTACT
Rank.Matthew@mayo.edu

Principal Investigator

Matthew Rank
PRINCIPAL_INVESTIGATOR
Phoenix Children's

Study Locations (Sites)

Phoenix Children's
Phoenix, Arizona, 85016
United States

Collaborators and Investigators

Sponsor: Phoenix Children's Hospital

  • Matthew Rank, PRINCIPAL_INVESTIGATOR, Phoenix Children's

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06
Study Completion Date2027-04

Study Record Updates

Study Start Date2025-06
Study Completion Date2027-04

Terms related to this study

Additional Relevant MeSH Terms

  • Asthma in Children