Colonic Motility in Constipation and Aging: A Study With a New 3D Transit System
Primary Purpose
Constipation
Status
Unknown status
Phase
Locations
Study Type
Observational
Intervention
MTS2
Sponsored by
About this trial
This is an observational trial for Constipation
Eligibility Criteria
Inclusion Criteria:
- Constipation
Exclusion Criteria:
- Constipation caused by other disease
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Arm Label
Constipated, Elderly
Constipation, Young
Normal Bowel, Elderly
Normal Bowel, Young
Arm Description
Investigation with MTS for motility
Investigation with MTS for motility
Investigation with MTS for motility
Investigation with MTS for motility
Outcomes
Primary Outcome Measures
Transit time through the small intestine and the colon. Both the total transit time, the regional transit times and the antegrade and retrograde movements are measured by the MTS system
The measurements will all be at least three days long, but can be up to 5 days depending on the rate of bowel movements.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02805959
Brief Title
Colonic Motility in Constipation and Aging: A Study With a New 3D Transit System
Official Title
Colonic Motility in Constipation and Aging: A Pilot Study With a New 3D Transit System
Study Type
Observational
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To study the motility of the bowel in constipated patients. Looking at the difference between young and elderly patients with constipation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
7. Study Design
Enrollment
20 (Anticipated)
Target Follow-Up Duration
1 Week
8. Arms, Groups, and Interventions
Arm Title
Constipated, Elderly
Arm Description
Investigation with MTS for motility
Arm Title
Constipation, Young
Arm Description
Investigation with MTS for motility
Arm Title
Normal Bowel, Elderly
Arm Description
Investigation with MTS for motility
Arm Title
Normal Bowel, Young
Arm Description
Investigation with MTS for motility
Intervention Type
Device
Intervention Name(s)
MTS2
Primary Outcome Measure Information:
Title
Transit time through the small intestine and the colon. Both the total transit time, the regional transit times and the antegrade and retrograde movements are measured by the MTS system
Description
The measurements will all be at least three days long, but can be up to 5 days depending on the rate of bowel movements.
Time Frame
The total transit time will differ between healthy and constipated but probably between 3-5 days.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Constipation
Exclusion Criteria:
Constipation caused by other disease
Study Population Description
Women with constipation
Sampling Method
Probability Sample
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Colonic Motility in Constipation and Aging: A Study With a New 3D Transit System
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