A Clinical Trial of Soluble Fiber for Asthma

NCT06372249 | Recruiting Phase 2

• 2 other identifiers: 22-2492U54MD012388-06
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• Alpha diversity.

  A total of 84 participants is required to find significant difference of 54 units of Richness at 90% power with a small effect size. Alpha diversity is used to measure the abundance that individual microbes can be observed. Statistical analysis is used to generate the significance of stool sample diversity as well as how many participants are needed to see the marker.

  6 weeks

Secondary Outcomes (4)

• Asthma control.

  6 weeks

• Gut microbiome composition.

  6 weeks

• Nasal inflammatory response.

  6 weeks

• Quantification of circulating short chain fatty acids.

  6 weeks

Study Arms (2)

Fiber Consumption and the Gut Microbiome Composition in a Pediatric Asthma Cohort

NO INTERVENTION

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.

A Phase II Randomized Controlled Trial of Soluble Fiber for Asthma

PLACEBO COMPARATOR

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.

Drug: Inulin

Interventions

Inulin DRUG

Soluble tapioca starch from Ingredion.

Also known as: Fruitafit CLR

A Phase II Randomized Controlled Trial of Soluble Fiber for Asthma

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You 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 may not qualify 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

Sponsors & Collaborators

• Phoenix Children's Hospital: lead
• Northern Arizona University: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• Southwest Health Engagement and Research Collaborative: collaborator
• SHERC: collaborator

Study Sites (1)

Phoenix Children's

Phoenix, Arizona, 85016, United States

RECRUITING

MeSH Terms

Conditions

Asthma; Hypersensitivity; Environmental Illness

Interventions

Inulin

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases; Disorders of Environmental Origin

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides

Study Officials

• Matthew Rank

  Phoenix Children's

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Gastaldo

CONTACT

6029334979; dgastaldo@phoenixchildrens.com

Matthew Rank

CONTACT

Rank.Matthew@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 17, 2024
• Study Start: November 10, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: March 4, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)