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Soluble Fiber

NOVELOSETM 3490 for Childhood Asthma

Phase 2

Recruiting

Led By Matthew Rank

Research Sponsored by Phoenix Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

Study Summary

"This trial will investigate the effects of soluble fiber on asthma. Participants will be given either soluble fiber or a placebo, and their gut microbes will be analyzed through blood, fecal, and nasal samples.

Who is the study for?

This trial is for children and adults with asthma. Participants must complete a dietary recall questionnaire to assess their fiber intake. They should be willing to take additional soluble fiber or placebo as part of the study.Check my eligibility

What is being tested?

The trial is testing whether adding soluble fiber (NOVELOSETM 3490) to the diet can improve asthma symptoms. It's a randomized controlled trial, meaning people are randomly assigned to receive either the fiber supplement or a placebo.See study design

What are the potential side effects?

While specific side effects aren't listed, typical side effects from taking soluble fiber supplements may include bloating, gas, cramping, or diarrhea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Alpha diversity.

Secondary outcome measures

Asthma control.

Gut microbiome composition.

Nasal inflammatory response.

+1 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Fiber Consumption and the Gut Microbiome Composition in a Pediatric Asthma CohortActive Control1 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.

Group II: A Phase II Randomized Controlled Trial of Soluble Fiber for AsthmaPlacebo Group1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Northern Arizona UniversityOTHER

32 Previous Clinical Trials

6,617 Total Patients Enrolled

Phoenix Children's HospitalLead Sponsor

74 Previous Clinical Trials

5,013,910 Total Patients Enrolled

National Institute on Minority Health and Health Disparities (NIMHD)NIH

383 Previous Clinical Trials

1,216,254 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the safety profile of NOVELOSETM 3490 in patients?

"According to our team at Power, NOVELOSETM 3490 has been rated a 2 in terms of safety. This rating is due to the ongoing Phase 2 trial which indicates some evidence supporting its safety profile but lacks data on efficacy."

Answered by AI

Which individuals are eligible to participate in this clinical research study?

"To be eligible for this research, subjects must have a history of asthma during childhood and fall within the age range of 6 to 17 years. The study has availability for up to 105 potential participants."

Answered by AI

Are patients currently able to enroll in this ongoing medical study?

"Indeed, as per clinicaltrials.gov data, this investigation is currently seeking volunteers. It was initially listed on 4/2/2024 and last revised on 4/12/2024. The trial aims to enroll 105 participants at a single location."

Answered by AI

What is the current participation count in this clinical trial?

"Yes, the details on clinicaltrials.gov indicate that this research is currently enrolling subjects. The study was initially posted on April 2nd, 2024 and last updated on April 12th, 2024. Recruitment aims to include 105 patients at a single site."

Answered by AI

Are individuals who are older than 65 eligible to participate in this research study?

"Individuals aged between 6 and 17 years are eligible for participation in this research endeavor. Among the available clinical trials, there are 139 studies tailored for minors under 18 and 206 focused on individuals over the age of retirement."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Clinical Trial of Soluble Fiber for Asthma

2024. "A Clinical Trial of Soluble Fiber for Asthma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06372249.

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