A Phase ll Randomized Controlled Trial of Soluble Fiber for Asthma
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 17
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
Phoenix Children's
RECRUITING
Phoenix
Contact Information
Primary
Daniel Gastaldo
dgastaldo@phoenixchildrens.com
6029334979
Backup
Matthew Rank
Rank.Matthew@mayo.edu
Time Frame
Start Date:2025-11-10
Estimated Completion Date:2027-05-31
Participants
Target number of participants:105
Treatments
No_intervention: Fiber Consumption and the Gut Microbiome Composition in a Pediatric Asthma Cohort
Participants are asked to complete a dietary recall questionnaire (ASA 24) that evaluates dietary intake in the last 24 hours. Participants are also sent home with a stool kit and instructions to collect a fecal sample for microbiome analysis. The purpose of the study is to better understand the pathways that connect diet and asthma.
Placebo_comparator: A Phase II Randomized Controlled Trial of Soluble Fiber for Asthma
Participants are asked to fill out a dietary recall questionnaire (ASA 24) to determine eligibility in the study. If eligible, a nasal wash and blood sample will be collected at the first visit. Study drug or placebo will be given to participant after their visit in a randomized double-blinded nature. The participant will also fil out an Asthma Control Questionnaire (ACQ) and be sent home with 3 stool kits for analysis. Participant will turn in one sample after first visit, the second in three weeks, and the last one after the second study visit. At this second study visit, procedures from the first study visit will be repeated.
Collaborators: Southwest Health Engagement and Research Collaborative, SHERC, Northern Arizona University, National Institute on Minority Health and Health Disparities (NIMHD)