Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-02-21 @ 3:52 PM
Study NCT ID:
NCT04282551
Status:
UNKNOWN
Last Update Posted:
2021-10-12
First Post:
2019-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Inside Study: Oligosaccharides Versus Placebo in Functional Constipation
Sponsor:
Wageningen University and Research
Organization:
Study Overview
Official Title:
The Effect of Oligosaccharides Versus a Placebo on Bowel Habits in Children With Functional Constipation
Status:
UNKNOWN
Status Verified Date:
2021-10
Last Known Status:
RECRUITING
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:
Inside
Brief Summary:
In the present randomised double blind controlled study, the investigators will study the effects of oligosaccharides vs a placebo on the change in stool consistency and stool frequency in children with functional constipation.
Detailed Description:
Functional constipation (FC) in children is a common gastrointestinal (GI) disorder with a worldwide prevalence ranging from 0.7% to 29.6%. Complaints include infrequent bowel movement, painful defecation due to hard and/or large stools, fecal incontinence, and abdominal pain. Although the condition is rarely life-threatening, it strongly impairs quality of life. Oligosaccharides have been shown to relieve constipation symptoms in young adults and elderly. However, sufficient evidence is lacking linking oligosaccharides intake to improve symptoms in children with FC. The investigators hypothesize that oligosaccharides might be able to relieve symptoms of constipation in young children as well, among which softening stools.
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?: