The Effect of Elemental Diet on Gastric Emptying (Elental)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Akira Horiuchi, Showa Inan General Hospital

ClinicalTrials.gov Identifier:

NCT01467765

First received: November 5, 2011

Last updated: August 7, 2012

Last verified: August 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	November 5, 2011
Last Updated Date	August 7, 2012
Start Date ^ICMJE	November 2011
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 5, 2011)	Measurement of gastric emptying [ Time Frame: Four hours (from 7:30 am to 11:30 am) ] [ Designated as safety issue: No ] 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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01467765 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	The Effect of Elemental Diet on Gastric Emptying
Official Title ^ICMJE	The Comparative Study of Elemental Diet and Regular Liquid Diet on Gastric Emptying in Patients With Percutaneous Endoscopic Gastrostomy
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.
Detailed Description
Study Type ^ICMJE	Interventional
Study Phase
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Postprocedural Delayed Gastric Emptying
Intervention ^ICMJE	Other: Elental 200Kcal/200mL of liquid nutrient for 15 min at 7:30 am is administered in PEG patients
Study Arm (s)	Active Comparator: Elemental diet Intervention: Other: Elental Placebo Comparator: Liquid nutrient Intervention: Other: Elental
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	20
Completion Date	April 2012
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: percutaneous endoscopic gastrostomy patients Exclusion Criteria: history of abdominal surgery
Gender	Both
Ages
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Japan

Administrative Information
NCT Number ^ICMJE	NCT01467765
Other Study ID Numbers ^ICMJE	Elental study
Has Data Monitoring Committee	No
Responsible Party	Akira Horiuchi, Showa Inan General Hospital
Study Sponsor ^ICMJE	Showa Inan General Hospital
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Showa Inan General Hospital
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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