Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:45 PM
Study NCT ID:
NCT02245594
Status:
UNKNOWN
Last Update Posted:
2014-09-19
First Post:
2014-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GI Symptoms and Sleep Disturbances in Patients With Quiescent Crohns Disease
Sponsor:
University of Aarhus
Organization:
Study Overview
Official Title:
Gastrointestinal Motility and Sleep Disturbances in Patients With Quiescent Crohn's Disease
Status:
UNKNOWN
Status Verified Date:
2014-09
Last Known Status:
NOT_YET_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:
None
Brief Summary:
In this study we would like to clarify the effect of long lasting Crohn's Disease on motility of the gastrointestinal system in patient and the effect regarding sleep disturbances. This will be done with a newly developed 3D-Motility-and-Transit-detector (Motilis Medica, Schweiz) and the well known polysomnographic equipment.
Our hypothesises are:
Patients with ileocoecal and/or colonic CD in remission and gastrointestinal symptoms have abnormal colonic transit (primary endpoint).
1. Patients with ileocoecal and/or colonic CD in remission and gastrointestinal symptoms have abnormal gastric emptying and small intestinal transit (secondary endpoints).
2. Total and segmental transit times found in patients with CD will be compared with corresponding transit times in healthy volunteers found in a previous study.
3. Patients with ileocoecal and/or colonic CD in remission have abnormal sleep patterns.
4. Nocturnal basic colonic activity, have changed in patients with ileocoecal and/or colonic CD in remission and sleep disturbances.
Our hypothesises are:
Patients with ileocoecal and/or colonic CD in remission and gastrointestinal symptoms have abnormal colonic transit (primary endpoint).
1. Patients with ileocoecal and/or colonic CD in remission and gastrointestinal symptoms have abnormal gastric emptying and small intestinal transit (secondary endpoints).
2. Total and segmental transit times found in patients with CD will be compared with corresponding transit times in healthy volunteers found in a previous study.
3. Patients with ileocoecal and/or colonic CD in remission have abnormal sleep patterns.
4. Nocturnal basic colonic activity, have changed in patients with ileocoecal and/or colonic CD in remission and sleep disturbances.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: