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A Clinical Trial of Soluble Fiber for Asthma

NCT ID: NCT06372249

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2027-04-30

Brief Summary

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Randomized controlled trial of soluble fiber (NOVELOSETM 3490). 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 (NOVELOSETM 3490) 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.

Detailed Description

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A Phase II randomized, controlled, clinical trial analyzing the impact of increasing fiber intake and the gut microbiome for children with asthma. If eligible, (determined by inclusions/exclusion criteria as well as fiber intake assess by ASA 24) participants will be put into a fiber (NOVELOSETM 3490) or placebo (Maltodextrin) group. Each participant will fil out an Asthma Control Questionnaire (ACQ), collect a nasal wash, and have their blood drawn. Their study medication will be available for them to pick up after their first visit, and they will receive counseling from the Pharmacist on how to implement it into their diet. They will also be sent home with three stool sample kits to be mailed to Northern Arizona University for microbiome analysis. The first kit will be sent within 7 days of their first visit. The second kit will be sent within 2-3 weeks of their first visit. The second study visit will occur 4-6 weeks after the first visit. All the procedures will be repeated again including taking the ASA 24 questionnaire. The participant will send their final kit within 7 days of completing their last visit. Total study time is 6 weeks. This study is minimal risk which includes risk of fecal contamination, discomfort from collecting specimens, discomfort with answering some of the survey questions, and the risks associated with receiving a blood draw. Participants are compensated for their time and receive a portion of their dietary results. There may not be a direct benefit to the participant, but by participating in this research they may help people in the future with asthma.

Conditions

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Asthma in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type PLACEBO_COMPARATOR

Inulin

Intervention Type DRUG

Soluble tapioca starch from Ingredion.

Interventions

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Inulin

Soluble tapioca starch from Ingredion.

Intervention Type DRUG

Other Intervention Names

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Fruitafit CLR

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northern Arizona University

OTHER

Sponsor Role collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

Phoenix Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew Rank

Role: PRINCIPAL_INVESTIGATOR

Phoenix Children's

Locations

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Phoenix Children's

Phoenix, Arizona, United States

Site Status

Countries

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United States

Central Contacts

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Daniel Gastaldo

Role: CONTACT

Phone: 6029334979

Email: [email protected]

Matthew Rank

Role: CONTACT

Email: [email protected]

Facility Contacts

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Destiny Ogbeama

Role: primary

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2U54MD012388-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22-249

Identifier Type: -

Identifier Source: org_study_id