Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-25 @ 1:44 AM
Study NCT ID:
NCT05213494
Status:
COMPLETED
Last Update Posted:
2022-01-28
First Post:
2021-12-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Soluble Corn Fiber on Gastrointestinal Tolerance and Fecal Microbiome in Healthy Children
Sponsor:
Tate & Lyle
Organization:
Study Overview
Official Title:
A Randomized, Controlled, Crossover Study to Assess the Effects of Soluble Corn Fiber on Gastrointestinal Tolerance and Fecal Microbiome in Healthy Children
Status:
COMPLETED
Status Verified Date:
2022-01
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:
The purpose of this study is to compare the effects of PROMITOR® Soluble Corn Fiber versus inulin on GI symptoms (tolerance), stool consistency (laxation) and fecal microbiome at levels that could contribute to closing the fiber gap. The dose response effects of PROMITOR® Soluble Corn Fiber in healthy children will also be compared.
Detailed Description:
After initial site visits and randomization children were given a packet of powdered fiber to be mixed into a beverage daily. There were four test arms, described elsewhere. Each study arm lasted 10 days with an 18 day washout in between study periods.
Study Oversight
Has Oversight DMC:
True
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?: