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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01635491

Enrollment

Registered

2012-07-09

Start date

2012-04-30

Completion date

2012-11-30

Last updated

2012-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Gastrointestinal Motility, Transit time

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Total gastrointestinal transit time in healthy subjects.	Three days from baseline visit

Secondary

Measure	Time frame
Segmental transit times in healthy subjects	Three days from Baseline visit

Countries

Denmark

Outcome results