ConstipationNCT02805959
Colonic Motility in Constipation and Aging: A Study With a New 3D Transit System
An observational study of Constipation, run by University of Aarhus.
Trial summary
To study the motility of the bowel in constipated patients. Looking at the difference between young and elderly patients with constipation. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Constipation
- What is being tested?
- MTS2
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Apr 2017
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women with constipation
Who may be able to join
- Constipation
Who cannot join
- Constipation caused by other disease
About this study
Official title: Colonic Motility in Constipation and Aging: A Pilot Study With a New 3D Transit System
To study the motility of the bowel in constipated patients. Looking at the difference between young and elderly patients with constipation.
- Conditions
- Constipation
- Being tested
- MTS2
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTS2Device
| Study group | Role | What they receive |
|---|---|---|
| Constipated, Elderly | Investigation with MTS for motility Receives: Device: MTS2 | |
| Constipation, Young | Investigation with MTS for motility Receives: Device: MTS2 | |
| Normal Bowel, Elderly | Investigation with MTS for motility Receives: Device: MTS2 | |
| Normal Bowel, Young | Investigation with MTS for motility Receives: Device: MTS2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The total transit time will differ between healthy and constipated but probably between 3-5 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 20 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805959
- Sponsor's protocol ID
- Fynne
- Status last verified
- Apr 2016
- First submitted
- 4 May 2016
- Last updated
- 21 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colonic Motility in Constipation and Aging: A Pilot Study With a New 3D Transit System
- ClinicalTrials.gov ID
- NCT02805959
- Acronym / sponsor ID
- Fynne
- Conditions
- Constipation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Apr 2017 (estimated)
- First posted
- 20 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the motility of the bowel in constipated patients. Looking at the difference between young and elderly patients with constipation.
Study design
- Target follow-up
- 1 Week
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Constipated, Elderly | – | Device: MTS2Investigation with MTS for motility |
| Constipation, Young | – | Device: MTS2Investigation with MTS for motility |
| Normal Bowel, Elderly | – | Device: MTS2Investigation with MTS for motility |
| Normal Bowel, Young | – | Device: MTS2Investigation with MTS for motility |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women with constipation
Key inclusion criteria (1 listed)
- Constipation
Key exclusion criteria (1 listed)
- Constipation caused by other disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MTS2 | Device | Constipated, Elderly, Constipation, Young, Normal Bowel, Elderly, Normal Bowel, Young |
Primary outcome
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
Time frame: The total transit time will differ between healthy and constipated but probably between 3-5 days.
The measurements will all be at least three days long, but can be up to 5 days depending on the rate of bowel movements.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Constipation, run by University of Aarhus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: The total transit time will differ between healthy and constipated but probably between 3-5 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2016; AzTrials last refreshed its copy on 2 Nov 2026.