Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
6 – 17
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
105 (estimated)
Sponsor
Phoenix Children's Hospital · Other
Who this trial is looking for
This trial is looking for kids and teens aged 6 to 17 who have been diagnosed with asthma in the last two years. They should not have any serious lung conditions and need to be stable with their asthma medications. Also, kids already signed up can't have siblings joining the study.
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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 …
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.
Trial Locations
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Eligibility Criteria
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
…
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
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