Asthma in ChildrenPhase 2NCT03673618
Soluble Corn Fiber Supplementation for Asthma
A Phase 2 study testing Soluble Corn Fiber in people with Asthma in Children, run by Phoenix Children's Hospital at 1 site in United States.
Trial summary
Studies of the importance of the human microbiome have demonstrated that microbial metabolites of fermentation of our dietary products (e.g. dietary fiber) have a multitude of health benefits. 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?
- Soluble Corn Fiber
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 31 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Clinical diagnosis of asthma
- Fractional excretion of exhaled nitric oxide (FeNO) > 50 ppb OR a history of environmental allergies
- No emergency department or hospital visits for asthma in the past 3 months
- No systemic corticosteroids in the past 1 month
- Ability to consume a liquid drink of SCF or placebo
- Ability to return for a 4-6 week follow-up visit
- No special or unique diet as determined by PI/CO-Is.
Who cannot join
- Cystic fibrosis
- Bronchiectasis
- Change in asthma medicines other than short acting bronchodilators planned over the next 4-6 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Studies of the importance of the human microbiome have demonstrated that microbial metabolites of fermentation of our dietary products (e.g. dietary fiber) have a multitude of health benefits. The investigators aim to determine whether supplementation of asthmatic children with soluble corn fiber alongside standard of care reduces airway inflammation driven by the gut microbial metabolites acetate, propionate, or butyrate (short chain fatty acids).
Read the detailed description
Asthma is a complex inflammatory disease of the airways that is estimated to affect 300 million people worldwide. Incidence of asthma is steadily increasing in Western populations; an additional 100 million asthma diagnoses are anticipated by the year 2025. Asthma is a multifactorial disease affected by genetic and environmental factors. One major and potentially modifiable environmental factor is the Western diet. The Western diet influences the microbiome, which in turn, may influence inflammatory airway diseases via a gut microbiome-airway connection. The investigators hypothesize that prebiotic dietary fiber supplementation leads to increased circulating short chain fatty acid production and improvement in asthma disease activity. The investigators will recruit 20 children, ages 6-17 years old, with asthma from the Severe Asthma Clinic or General Pulmonary Clinic at Phoenix Children's Hospital. Participants will be randomly assigned (1:1) using a random number generator to ingest PROMOTIR soluble corn fiber (85% fiber, 12 g/day) in a fruit-flavored beverage or placebo (malodextrin in a similar fruit-flavored beverage) as previously described. Participants will be asked to consume the prebiotic soluble corn fiber (or placebo) for 4 weeks alongside their normal diet and normal asthma treatments. Blood will be collected pre- and post-fiber intervention to measure baseline and post-intervention circulating SCFAs. Stool samples and nasal wash will be collected for microbiome and immune analysis pre- and post- fiber consumption. Nasal washes will be collected pre- and post-fiber consumption to measure inflammatory patterns.
- Conditions
- Asthma in Children
- Being tested
- Soluble Corn Fiber
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soluble Corn FiberDrug
Fiber or placebo
| Study group | Role | What they receive |
|---|---|---|
| PROMOTIR soluble corn fiber | Experimental | Participants will ingest PROMOTIR soluble corn fiber (85% fiber, 12 g/day) in a fruit-flavored beverage for 4 weeks alongside their normal diet and normal asthma treatments. Receives: Drug: Soluble Corn Fiber |
| Malodextrin | Placebo comparator | Participants will ingest malodextrin in a fruit-flavored beverage for 4 weeks alongside their normal diet and normal asthma treatments. Receives: Drug: Soluble Corn Fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma symptoms
Asthma Control Questionnaire
Measured: 4 weeks
Secondary outcomes (4)
Change in Serum Short Chain Fatty Acids
Measured: Before treatment period and after treatment for 4 weeks
Change in nasal wash Th2 gene expression
Measured: Before treatment period and after treatment for 4 weeks
Alpha and beta diversity in participants' nasal microbiome
Measured: Before treatment period and after treatment for 4 weeks
Alpha and beta diversity in participants' stool microbiome
Measured: Before treatment period and after treatment for 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start1 Sep 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phoenix Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Northern Arizona University, Flinn Foundation, Mayo Clinic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673618
- Sponsor's protocol ID
- Phoenixchildrens-18-121
- Status last verified
- Apr 2022
- First submitted
- 12 Sep 2018
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rank MA, Barroso DL, Conn KA, Pecak M, Scandura M, Hirsch AH, Gu H, Whisner CM, Shearer H, Johnson D, Argel N, Bauer CS, Williams SN, Wright BL, Woodward J, Cope EK. A randomized, double-blind, placebo-controlled trial of soluble corn fiber supplementation for children with asthma. Front Allergy. 2026 Jan 21;6:1707834. doi: 10.3389/falgy.2025.1707834. eCollection 2025.
PubMed 41647190
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soluble Corn Fiber Supplementation for Asthma
- ClinicalTrials.gov ID
- NCT03673618
- Acronym / sponsor ID
- Phoenixchildrens-18-121
- Conditions
- Asthma in Children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Phoenix Children's HospitalUniversity, hospital or other
- Collaborators
- Northern Arizona University, Flinn Foundation, Mayo Clinic
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 17 Sep 2018 (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.
Studies of the importance of the human microbiome have demonstrated that microbial metabolites of fermentation of our dietary products (e.g. dietary fiber) have a multitude of health benefits. The investigators aim to determine whether supplementation of asthmatic children with soluble corn fiber alongside standard of care reduces airway inflammation driven by the gut microbial metabolites acetate, propionate, or butyrate (short chain fatty acids).
Detailed description
Asthma is a complex inflammatory disease of the airways that is estimated to affect 300 million people worldwide. Incidence of asthma is steadily increasing in Western populations; an additional 100 million asthma diagnoses are anticipated by the year 2025. Asthma is a multifactorial disease affected by genetic and environmental factors. One major and potentially modifiable environmental factor is the Western diet. The Western diet influences the microbiome, which in turn, may influence inflammatory airway diseases via a gut microbiome-airway connection. The investigators hypothesize that prebiotic dietary fiber supplementation leads to increased circulating short chain fatty acid production and improvement in asthma disease activity. The investigators will recruit 20 children, ages 6-17 years old, with asthma from the Severe Asthma Clinic or General Pulmonary Clinic at Phoenix Children's Hospital. Participants will be randomly assigned (1:1) using a random number generator to ingest PROMOTIR soluble corn fiber (85% fiber, 12 g/day) in a fruit-flavored beverage or placebo (malodextrin in a similar fruit-flavored beverage) as previously described. Participants will be asked to consume the prebiotic soluble corn fiber (or placebo) for 4 weeks alongside their normal diet and normal asthma treatments. Blood will be collected pre- and post-fiber intervention to measure baseline and post-intervention circulating SCFAs. Stool samples and nasal wash will be collected for microbiome and immune analysis pre- and post- fiber consumption. Nasal washes will be collected pre- and post-fiber consumption to measure inflammatory patterns.
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 |
|---|---|---|
| PROMOTIR soluble corn fiber | Experimental | Drug: Soluble Corn FiberParticipants will ingest PROMOTIR soluble corn fiber (85% fiber, 12 g/day) in a fruit-flavored beverage for 4 weeks alongside their normal diet and normal asthma treatments. |
| Malodextrin | Placebo comparator | Drug: Soluble Corn FiberParticipants will ingest malodextrin in a fruit-flavored beverage for 4 weeks alongside their normal diet and normal asthma treatments. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Clinical diagnosis of asthma
- Fractional excretion of exhaled nitric oxide (FeNO) > 50 ppb OR a history of environmental allergies
- No emergency department or hospital visits for asthma in the past 3 months
- No systemic corticosteroids in the past 1 month
- Ability to consume a liquid drink of SCF or placebo
Key exclusion criteria (3 listed)
- Cystic fibrosis
- Bronchiectasis
- Change in asthma medicines other than short acting bronchodilators planned over the next 4-6 weeks.
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 |
|---|---|---|
| Soluble Corn FiberFiber or placebo | Drug | Malodextrin, PROMOTIR soluble corn fiber |
Primary outcome
Asthma symptoms
Time frame: 4 weeks
Asthma Control Questionnaire
4 secondary outcomes
Change in Serum Short Chain Fatty Acids
Time frame: Before treatment period and after treatment for 4 weeks
Change in nasal wash Th2 gene expression
Time frame: Before treatment period and after treatment for 4 weeks
Alpha and beta diversity in participants' nasal microbiome
Time frame: Before treatment period and after treatment for 4 weeks
Alpha and beta diversity in participants' stool microbiome
Time frame: Before treatment period and after treatment for 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Derived from this study: PubMed 41647190Rank MA, Barroso DL, Conn KA, Pecak M, Scandura M, Hirsch AH, Gu H, Whisner CM, Shearer H, Johnson D, Argel N, Bauer CS, Williams SN, Wright BL, Woodward J, Cope EK. A randomized, double-blind, placebo-controlled trial of soluble corn fiber supplementation for children with asthma. Front Allergy. 2026 Jan 21;6:1707834. doi: 10.3389/falgy.2025.1707834. eCollection 2025.
Related trials for Asthma in Children
Not yet recruiting
Bilevel Positive Airway Pressure (BPAP) for Severe Asthma
Pediatric Asthma, Acute Asthma
Not yet recruiting
Artificially Intelligent Robot Control
Asthma in Children, Artificial Intelligence
Enrolling by invitationObservational study
Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children.
Lung Diseases
Recruiting
Effects of Tele-rehabilitation-Guided Qigong on Children and Adolescents With Asthma
Asthma Childhood
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Soluble Corn Fiber 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 3 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: finished, as of the sponsor's last update on 31 Mar 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma symptoms (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03673618, which also lists 1 linked publication.
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 31 Mar 2023.