- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01467765
The Effect of Elemental Diet on Gastric Emptying (Elental)
August 7, 2012 updated by: Akira Horiuchi, Showa Inan General Hospital
The Comparative Study of Elemental Diet and Regular Liquid Diet on Gastric Emptying in Patients With Percutaneous Endoscopic Gastrostomy
In patients with percutaneous endoscopic gastrostomy (PEG) delayed gastric emptying has been speculated as a cause of aspiration pneumonia.
Elemental diet may facilitate gastric emptying in PEG patients as compared with regular liquid enteral nutrients, resulting in the prevention of aspiration pneumonia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nagano
-
Komagane, Nagano, Japan, 399-4117
- Showa Inan General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- percutaneous endoscopic gastrostomy patients
Exclusion Criteria:
- history of abdominal surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Elemental diet
|
200Kcal/200mL of liquid nutrient for 15 min at 7:30 am is administered in PEG patients
|
Placebo Comparator: Liquid nutrient
|
200Kcal/200mL of liquid nutrient for 15 min at 7:30 am is administered in PEG patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of gastric emptying
Time Frame: Four hours (from 7:30 am to 11:30 am)
|
Two kinds of liquid test meals (Elemenal diet or regular liquid nutrient ) (200kcal/200ml) labeled with 100 mg(13C sodium acetate) are administered for 15 min and after that 13C breath test performed during the 4 hours
|
Four hours (from 7:30 am to 11:30 am)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
November 5, 2011
First Submitted That Met QC Criteria
November 5, 2011
First Posted (Estimate)
November 9, 2011
Study Record Updates
Last Update Posted (Estimate)
August 9, 2012
Last Update Submitted That Met QC Criteria
August 7, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Elental study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Elental
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