Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06372249
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-03
Brief Title:
A Clinical Trial of Soluble Fiber for Asthma
Sponsor:
Phoenix Childrens Hospital
Organization:
Phoenix Childrens Hospital
Study Overview
Official Title:
A Phase ll Randomized Controlled Trial of Soluble Fiber for Asthma
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 ones 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 ones 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 inclusionsexclusion 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2U54MD012388-06 | NIH | None | httpsreporternihgovquickSearch2U54MD012388-06 |