NCT02805959

Brief Summary

To study the motility of the bowel in constipated patients. Looking at the difference between young and elderly patients with constipation.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2016

Completed
28 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 20, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Last Updated

June 21, 2016

Status Verified

April 1, 2016

Enrollment Period

10 months

First QC Date

May 4, 2016

Last Update Submit

June 19, 2016

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

  • 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.

    The total transit time will differ between healthy and constipated but probably between 3-5 days.

Study Arms (4)

Constipated, Elderly

Investigation with MTS for motility

Device: MTS2

Constipation, Young

Investigation with MTS for motility

Device: MTS2

Normal Bowel, Elderly

Investigation with MTS for motility

Device: MTS2

Normal Bowel, Young

Investigation with MTS for motility

Device: MTS2

Interventions

MTS2DEVICE
Constipated, ElderlyConstipation, YoungNormal Bowel, ElderlyNormal Bowel, Young

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women with constipation

You may qualify if:

  • Constipation

You may not qualify if:

  • Constipation caused by other disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2016

First Posted

June 20, 2016

Study Start

June 1, 2016

Primary Completion

April 1, 2017

Last Updated

June 21, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share