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

Completed

• Conditions: Gastrointestinal Motility; Total Gastrointestinal Transit Time; Segmental Transit Time; Gastric Emptying

• Registration Number: NCT01635491
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-06-26
• Study First Submitted QC: 2012-07-04
• Study First Posted: 2012-07-09
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-06
• Last Update Posted: 2012-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total gastrointestinal transit time in healthy subjects.	Three days from baseline visit

Secondary Outcome Measures

Name	Time	Method
Segmental transit times in healthy subjects	Three days from Baseline visit

Trial Locations

Locations (1)

Aarhus University Hospital, Department of Hepato and Gastroenterolegy; 🇩🇰 Aarhus, Denmark