A Clinical Trial of Soluble Fiber for Asthma

Status Recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06372249
Study type	Interventional
Source	Phoenix Children's Hospital
Contact	Destiny Ogbeama
Phone	6029332223
Email	dogbeama@phoenixchildrens.com
Status	Recruiting
Phase	Phase 2
Start date	April 2, 2024
Completion date	April 2027

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04450108` - Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients	N/A
Recruiting	`NCT05734261` - Forced Oscillations Technique During a Metacholine Test in Children	N/A
Recruiting	`NCT06044051` - Dynamics of the Upper and Lower Airway Respiratory Microbiomes Associated With Severe Infant Asthma	N/A
Completed	`NCT04896502` - Effectiveness of Telemedicine Home Assessments for Identification and Reduction of Asthma Triggers	N/A
Completed	`NCT03503812` - Mitigating the Health Effects of Desert Dust Storms Using Exposure-Reduction Approaches	N/A
Not yet recruiting	`NCT05902702` - Isotonic Saline for Children With Bronchiolitis	N/A
Not yet recruiting	`NCT05547477` - Continuous EMG Measurements in Children With Asthma During Sleep
Completed	`NCT04388098` - Oral Health Status of Asthmatic Children
Terminated	`NCT03586544` - Reducing Exercise-induced Bronchoconstriction in Children With Asthma and Obesity	Phase 4
Recruiting	`NCT04821908` - Consequences of COVID 19 Pandemic on Childhood Asthma
Not yet recruiting	`NCT03277170` - Pragmatic RCT of High-dose Oral Montelukast for Moderate and Severe Pediatric Acute Asthma Exacerbations	Phase 2
Enrolling by invitation	`NCT06239844` - Navigating Together for Equitable Asthma Management for Children in Families Who Communicate in Language Other Than English	N/A
Recruiting	`NCT06003569` - Reducing Asthma Attacks in Disadvantaged School Children With Asthma	N/A
Not yet recruiting	`NCT05974917` - Serious gaMes as Emerging E-health Interventions for Young People With neurologicaL or rEspiratory disoRders
Not yet recruiting	`NCT05997784` - Study of Indoor Air Pollutants and Their Impact in Childhood Health and Wellbeing
Recruiting	`NCT05366309` - Performance and Adherence in Children Using Spacers	N/A
Completed	`NCT05684926` - COVID-19 Pandemic Asthma Child Telerehabilitation Yoga	N/A
Recruiting	`NCT04166344` - A mHealth Intervention to Improve Symptom Control in Children and Adolescents With Difficult-to-control Asthma	N/A
Completed	`NCT05576142` - Oral Findings in Pediatric Patients With Allergic Rhinitis and/or Asthma
Completed	`NCT03907410` - The Tailored Adherence Incentives for Childhood Asthma Medications (TAICAM) Trial	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.