A Clinical Trial of Soluble Fiber for Asthma

Asthma in Children Clinical Trial

Official title:

A Phase ll Randomized Controlled Trial of Soluble Fiber for Asthma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06372249
• Other study ID #: 22-249
• Secondary ID: 2U54MD012388-06
• Status: Recruiting
• Phase: Phase 2
• Start date: April 2, 2024
• Est. completion date: April 2027

Study information

• Verified date: April 2024
• Source: Phoenix Children's Hospital
• Contact: Destiny Ogbeama
• Phone: 6029332223
• Email: dogbeama[@]phoenixchildrens.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized controlled trial of soluble fiber (NOVELOSETM 3490). 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 (NOVELOSETM 3490) 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.

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 (NOVELOSETM 3490) 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 analysis. The first kit will be sent within 7 days of their first visit. The second kit will be sent within 2-3 weeks of their first visit. The second study visit will occur 4-6 weeks 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 6 weeks. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: April 2027
• Est. primary completion date: April 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

Drug:
• NOVELOSETM 3490
Soluble tapioca starch from Ingredion.

Locations

Country	Name	City	State
United States	Phoenix Children's	Phoenix	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Phoenix Children's Hospital	National Institute on Minority Health and Health Disparities (NIMHD), Northern Arizona University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks
Secondary	Asthma control.	Assessed via Asthma Control Questionnaire. Scores can range from 0 to 6. With a higher score indicating poor asthma control.	6 weeks
Secondary	Gut microbiome composition.	Analysis of gut microbiome using quantitative polymerase chain reaction (qPCR) and analysis of variance (ANOVA).	6 weeks
Secondary	Nasal inflammatory response.	Measured via quantitative polymerase chain reaction (qPCR).	6 weeks
Secondary	Quantification of circulating short chain fatty acids.	Obtained from analysis of fecal specimen.	6 weeks