Ignite Creation Date:
2024-07-17 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06488534
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2023-09-12
Brief Title:
Intracolonic FODMAP Infusion in Healthy Volunteers
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
The Effect of Intracolonic Infusion of FODMAPS on Colonic Motility and Symptoms in Healthy Volunteers
Status:
RECRUITING
Status Verified Date:
2024-06
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:
ICOF
Brief Summary:
Irritable bowel syndrome IBS is one of the most common chronic diseases of the gut-brain axis The underlying pathophysiology is multifactorial poorly understood and differs between the subtypes constipation-dominant IBS diarrhea-dominant IBS mixed IBS and unspecified IBS Although it is considered a motility disorder no uniform motility patterns have been found in IBS patients and no link has yet been found between the motility patterns and the typical complaints such as nausea fullness cramps and flatulence These symptoms are often diagnosed after a meal and research has shown that especially fermentable oligo di monosaccharides and polyols FODMAPs give rise to symptoms Many studies have tested the effect of these FODMAPs after oral administration but little is known about their direct effect on the colon In this double-blind cross-over study 15 healthy volunteers are subjected to 3 colonoscopies in which a catheter is placed to measure the pressures in the large intestine and to administer the dissolved FODMAPs Volunteers will follow a diet low in fiber and FODMAPs 3 days before each study visit In addition they will have to record their daily bowel movements during the week of their study visit and fill in 2 short questionnaires on the day of the study visit regarding their gastrointestinal complaints There will be at least 2 weeks between the 3 study visits to avoid any overlap between the FODMAPs
Detailed Description:
None
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