A Clinical Trial of Soluble Fiber for Asthma

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Phoenix Children's Hospital
Study ID
NCT06372249
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Asthma in Children

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Inulin — DRUG
    Soluble tapioca starch from Ingredion.

Study Details

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.

Key Dates

Start date
Nov 10, 2025
Status verified
Sep 2025
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
105 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Alpha diversity. [ Time Frame: 6 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Phoenix Children'sPhoenixArizona85016
Daniel Gastaldo
[email protected]
602-933-4979

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