What this study is
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.
What's being tested
- Inulin
Intervention · DRUG
Soluble tapioca starch from Ingredion.
Study details
- Official title
- A Phase ll Randomized Controlled Trial of Soluble Fiber for Asthma
- Sponsor
- Phoenix Children's Hospital
- Conditions
- Asthma in Children
- Enrolling
- 105 people
- Starts
- 2025-12
- Est. completion
- 2027-04
- Design
- Quadruple-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 6 Years – 17 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openPhoenix Children's
Phoenix, Arizona, United States
- Destiny Ogbeama · Contact
Study team
Sponsor
Phoenix Children's Hospital
Study ID 22-249
Principal investigator
Matthew Rank
Phoenix Children's
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.