Health TrialsbyHealthPanel

A Clinical Trial of Soluble Fiber for Asthma

ConditionAsthma in Children
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age6-17
SponsorPhoenix Children's Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Inulin

    Drug

    Soluble tapioca starch from Ingredion.

Treatment groups

105 Participants
are divided into 2 treatment groups
Group A: Fiber Consumption and the Gut Microbiome Composition in a Pediatric Asthma CohortNo intervention 0 interventions
Group B: A Phase II Randomized Controlled Trial of Soluble Fiber for AsthmaPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
6 weeks

Secondary outcomes

1

Asthma control.

Assessed via Asthma Control Questionnaire. Scores can range from 0 to 6. With a higher score indicating poor asthma control.

Time frame
6 weeks
2

Gut microbiome composition.

Analysis of gut microbiome using quantitative polymerase chain reaction (qPCR) and analysis of variance (ANOVA).

Time frame
6 weeks
3

Nasal inflammatory response.

Measured via quantitative polymerase chain reaction (qPCR).

Time frame
6 weeks
4

Quantification of circulating short chain fatty acids.

Short chain fatty acids (SCFAs) will be collected and analyzed via microbiome and metabolomic analyses of stool samples and blood serum samples.

Time frame
6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Phoenix Children's Hospital

Lead sponsor

Northern Arizona University

Collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Southwest Health Engagement and Research Collaborative

Collaborator

SHERC

Collaborator

Source ClinicalTrials.gov
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