Asthma in ChildrenPhase 2NCT06372249
A Clinical Trial of Soluble Fiber for Asthma
A Phase 2 study testing Inulin in people with Asthma in Children, run by Phoenix Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Inulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2025to 31 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Matthew Rank contact
United States1 site, 1 recruiting
- Recruiting
Phoenix Children's
Phoenix, Arizona, 85016
Daniel Gastaldo, 602-933-4979, dgastaldo@phoenixchildrens.com
About this study
Official title: A Phase ll Randomized Controlled Trial of Soluble Fiber for Asthma
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.
Read the detailed 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.
- Conditions
- Asthma in Children
- Being tested
- Inulin
- 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
- Medical subject headings
- Asthma, Hypersensitivity, Environmental Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InulinDrug
Also called Fruitafit CLR
Soluble tapioca starch from Ingredion.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Inulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (4)
Asthma control.
Assessed via Asthma Control Questionnaire. Scores can range from 0 to 6. With a higher score indicating poor asthma control.
Measured: 6 weeks
Gut microbiome composition.
Analysis of gut microbiome using quantitative polymerase chain reaction (qPCR) and analysis of variance (ANOVA).
Measured: 6 weeks
Nasal inflammatory response.
Measured via quantitative polymerase chain reaction (qPCR).
Measured: 6 weeks
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start10 Nov 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phoenix Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Northern Arizona University, National Institute on Minority Health and Health Disparities (NIMHD), Southwest Health Engagement and Research Collaborative, SHERC
- Responsible party
- Sponsor
- Investigators
- Matthew Rank, Principal investigator, Phoenix Children's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06372249
- Sponsor's protocol ID
- 22-249
- Other IDs
- 2U54MD012388-06
- Status last verified
- Sep 2025
- First submitted
- 3 Apr 2024
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase ll Randomized Controlled Trial of Soluble Fiber for Asthma
- ClinicalTrials.gov ID
- NCT06372249
- Acronym / sponsor ID
- 22-249
- Conditions
- Asthma in Children
- Keywords
- Asthma, Mild Asthma, Moderate Asthma, Severe Asthma, Allergies, Environmental Allergies, Controlled Asthma, Well-Controlled Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Phoenix Children's HospitalUniversity, hospital or other
- Collaborators
- Northern Arizona University, National Institute on Minority Health and Health Disparities (NIMHD), Southwest Health Engagement and Research Collaborative, SHERC
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: InulinParticipants 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. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InulinAlso: Fruitafit CLRSoluble tapioca starch from Ingredion. | Drug | A Phase II Randomized Controlled Trial of Soluble Fiber for Asthma |
Primary outcome
Alpha diversity.
Time frame: 6 weeks
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.
4 secondary outcomes
Asthma control.
Time frame: 6 weeks
Gut microbiome composition.
Time frame: 6 weeks
Nasal inflammatory response.
Time frame: 6 weeks
Quantification of circulating short chain fatty acids.
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew Rank contact
Matthew Rank principal investigator
Phoenix Children's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inulin in people with Asthma in Children, run by Phoenix Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Gastaldo (6029334979, dgastaldo@phoenixchildrens.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alpha diversity. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.