Functional Disorders of Stomach Clinical Trial
— ANTERO-AC-1Official title:
A Pilot Study to Investigate Whether Intragastric Pressure During Food Intake Can be Measured Using an Intragastric Bag in Healthy Volunteers
| Verified date | April 2018 |
| Source | Universitaire Ziekenhuizen Leuven |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
In this pilot study the investigators test the hypothesis that gastric motility can be measured with an intragastric balloon.
| Status | Completed |
| Enrollment | 6 |
| Est. completion date | February 2016 |
| Est. primary completion date | January 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility |
Inclusion Criteria: - They are between 18-60 years old. - Male and female. - Patients must provide witnessed written informed consent prior to any study procedures being performed. Exclusion Criteria: - They are older than 60 years old. - Have severely decreased kidney function. - Have severely decreased liver function. - Have severe heart disease, for example a history of irregular heartbeats, angina or heart attack. - Have severe lung disease. - Have severe psychiatric illness or neurological illness. - Have any gastrointestinal disease. - Have any dyspeptic symptoms. - Women that are pregnant or breastfeeding. |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | UZLeuven | Leuven |
| Lead Sponsor | Collaborator |
|---|---|
| Prof Dr Jan Tack |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Intragastric pressure during food intake | The intragastric pressure determined with the manometer and the intragastric bag will be compare before, during and after nutrient drink infusion. | max 3 hours |