Back to resultsThe Effect of Elemental Diet on Gastric Emptying (Elental)
Primary Purpose
Postprocedural Delayed Gastric Emptying
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Elental
Sponsored by
About this trial
This is an interventional treatment trial for Postprocedural Delayed Gastric Emptying
Eligibility Criteria
Inclusion Criteria:
- percutaneous endoscopic gastrostomy patients
Exclusion Criteria:
- history of abdominal surgery
Sites / Locations
- Showa Inan General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Elemental diet
Liquid nutrient
Arm Description
Outcomes
Primary Outcome Measures
Measurement of gastric emptying
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01467765
First Posted
November 5, 2011
Last Updated
August 7, 2012
Sponsor
Showa Inan General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01467765
Brief Title
The Effect of Elemental Diet on Gastric Emptying
Acronym
Elental
Official Title
The Comparative Study of Elemental Diet and Regular Liquid Diet on Gastric Emptying in Patients With Percutaneous Endoscopic Gastrostomy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Showa Inan General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postprocedural Delayed Gastric Emptying
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Elemental diet
Arm Type
Active Comparator
Arm Title
Liquid nutrient
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Elental
Intervention Description
200Kcal/200mL of liquid nutrient for 15 min at 7:30 am is administered in PEG patients
Primary Outcome Measure Information:
Title
Measurement of gastric emptying
Description
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
Time Frame
Four hours (from 7:30 am to 11:30 am)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
percutaneous endoscopic gastrostomy patients
Exclusion Criteria:
history of abdominal surgery
Facility Information:
Facility Name
Showa Inan General Hospital
City
Komagane
State/Province
Nagano
ZIP/Postal Code
399-4117
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
The Effect of Elemental Diet on Gastric Emptying
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