Gastrointestinal Transit Times and Motility in Healthy Volunteers Obtained by Motilis-3D-transit

December 6, 2012 updated by: University of Aarhus

The purpose of this study is to describe gastrointestinal motility and transit times in healthy subjects by using Motilis 3D-Transit and to compare the total gastrointestinal transit time (GITT) to GITT obtained using radioopaque markers.

The investigators end points are to measure the transit times through different segments of the gastrointestinal canal,e.g. gastric emptying, small intestine, total GITT.

The study is descriptive and is designed to test and evaluate the usefulness of the Motilis 3D-Transit system. The investigators hypothesize, that with the system transit times through different segments of the gastrointestinal canal can be measured.

The design is made for evaluating the transit times, the inter-subject reproducibility and comparison with gold standard for colonic transit time measurement.

The investigators have chosen to include 20 healthy volunteers.The study is descriptive and therefore power calculation is not needed.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Aarhus University Hospital, Department of Hepato and Gastroenterolegy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy Volunteers

Description

Inclusion Criteria:

  • Healthy Volunteer
  • Signed informed consent obtained
  • Fasted since midnight

Exclusion Criteria:

  • Subject has known GI related symptoms complaints or GI diseases, including swallowing disorders
  • Subject has cancer or other life threatening diseases or conditions
  • Subject is pregnant
  • Subject has undergone abdominal surgery
  • Subject has abdominal diameter >140cm?
  • Drug abuse or alcoholism
  • Subject's bowel movements are irregular
  • Subject has known cardiovascular or pulmonary diseases
  • Participation in any clinical study within the last 30 days
  • Subject has cardiac pacemaker or infusion pump or any other implanted or portable electro-mechanical medical device.
  • Subject takes any medication affecting GI motility
  • Subject having MRI within the next four weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total gastrointestinal transit time in healthy subjects.
Time Frame: Three days from baseline visit
Three days from baseline visit

Secondary Outcome Measures

Outcome Measure
Time Frame
Segmental transit times in healthy subjects
Time Frame: Three days from Baseline visit
Three days from Baseline visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Motilis,Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

June 26, 2012

First Submitted That Met QC Criteria

July 4, 2012

First Posted (Estimate)

July 9, 2012

Study Record Updates

Last Update Posted (Estimate)

December 7, 2012

Last Update Submitted That Met QC Criteria

December 6, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • M-20100267

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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