A Clinical Trial of Soluble Fiber for Asthma
ConditionAsthma in Children
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age6-17
SponsorPhoenix Children's Hospital
About this trial
Randomized controlled trial of soluble fiber (Fruitafit Inulin). 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 (Fruitafit Inulin) 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Inulin
Treatment groups
105 Participants
are divided into 2 treatment groupsSponsors and collaborators
Phoenix Children's Hospital
Lead sponsor
Northern Arizona University
Collaborator
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Southwest Health Engagement and Research Collaborative
Collaborator
SHERC
Collaborator
Source ClinicalTrials.gov