Recruiting
Phase 2

Fruitafit Inulin

Sponsor:

Phoenix Children's Hospital

Code:

NCT06372249

Conditions

Asthma in Children

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Interventions

Inulin

Study Details

Brief 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.

Conditions

Asthma in Children

Study ID

NCT06372249

Start date

Nov 10, 2025

Status verified date

Sep, 2025

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

105 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Inulin

Soluble tapioca starch from Ingredion.

Primary outcome measure

  • Alpha diversity. [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Daniel Gastaldo

6029334979dgastaldo@phoenixchildrens.com

Matthew Rank

Rank.Matthew@mayo.edu

Locations

Phoenix Children's

Recruiting

Phoenix, Arizona, United States, 85016

Contacts

Daniel Gastaldo

602-933-4979dgastaldo@phoenixchildrens.com

More Information

Sponsor

Phoenix Children's Hospital

Last update posted

Mar 4, 2026

Last verified

Sep, 2025

Keywords

  • Asthma
  • Mild Asthma
  • Moderate Asthma
  • Severe Asthma
  • Allergies
  • Environmental Allergies
  • Controlled Asthma
  • Well-Controlled Asthma
  • Diet
  • Dietary Fiber
  • Dietary Supplementation
  • Micro-biome
  • Gut-microbiome
  • Children
  • Child
  • Microbiome Analysis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Phoenix Children's Hospital on 2026-03-04.