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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
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Constipation

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    May 4, 2016
    Last Updated
    June 19, 2016
    Sponsor
    University of Aarhus
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    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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