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

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.

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Key information

Conditions

Gastrointestinal Motility Gastric Emptying Segmental Transit Time Total Gastrointestinal Transit Time

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital, Department of Hepato and Gastroenterolegy

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Total gastrointestinal transit time in healthy subjects.

Time frame: Three days from baseline visit

Secondary outcomes

Segmental transit times in healthy subjects

Time frame: Three days from Baseline visit

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

Motilis,Switzerland

Registry information

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Jul 9, 2012
Registry last updated: Dec 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed