A Clinical Trial of Soluble Fiber for Asthma

Phase

Condition

Allergy

Asthma

Allergies & Asthma

Treatment

NOVELOSETM 3490

Inulin

Clinical Study ID

NCT06372249

22-249

2U54MD012388-06

Ages 6-17
All Genders

Study 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 Criteria

Inclusion

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 historyof environmental allergies as defined by a positive skin prick or positive specificimmunoglobulin 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

Exclusion Criteria:

Cystic fibrosis
Bronchiectasis
Change in asthma medicines other than short acting bronchodilators planned over thenext 4-6 weeks
Baseline estimated daily fiber intake less than or equal to 16 grams as determinedby the ASA 24
Sibling of a participant already enrolled in the study

Study Design

NOVELOSETM 3490

November 10, 2025

May 31, 2027

Study Description

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 (Fruitafit Inulin) 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 and metabolomic analysis. The first kit will be sent within 7 days of their first visit. The second kit will be sent within 14 days (+/- 1 day) of their first visit. The second study visit will occur 25 days (+5 days) 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 approx 30 days. 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.

Connect with a study center

Phoenix Children's
Phoenix, Arizona 85016
United States
Active - Recruiting
Phoenix Children's
Phoenix 5308655, Arizona 5551752 85016
United States
Site Not Available

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