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

NCT01635491 | Completed DMC

• 1 other identifier: M-20100267
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Motility; Total Gastrointestinal Transit Time; Segmental Transit Time; Gastric Emptying

Keywords

Gastrointestinal Motility; Transit time

Outcome Measures

Primary Outcomes (1)

• Total gastrointestinal transit time in healthy subjects.

  Three days from baseline visit

Secondary Outcomes (1)

• Segmental transit times in healthy subjects

  Three days from Baseline visit

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Volunteers

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Motilis,Switzerland: collaborator

Study Sites (1)

Aarhus University Hospital, Department of Hepato and Gastroenterolegy

Aarhus, 8000, Denmark

Location

Study Officials

• AnneMette Haase, Ph.D Student

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2012
• First Posted: July 9, 2012
• Study Start: April 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: December 7, 2012

Record last verified: 2012-12

Locations

DK (1)