The Effect of Elemental Diet on Gastric Emptying | NCT01467765

Studies
The Effect of Elemental Diet on Gastric Emptying

NCT01467765

Sponsor

Showa Inan General Hospital

Status

Completed

Last Update Posted

Aug 9, 2012Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Postprocedural Delayed Gastric Emptying

Interventions

Elental

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Apr 2012Actual

Completion Date

Apr 2012Actual

First Submitted Date

Nov 5, 2011

First Submission Date that Met QC Criteria

Nov 5, 2011

First Posted Date

Nov 9, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2012

Last Update Posted Date

Aug 9, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Akira Horiuchi, Chief, Digestive Disease Center, Showa Inan General HospitalPrincipal Investigator

Lead Sponsor

Showa Inan General HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Elemental diet	Active Comparator		Other: Elental
Liquid nutrient	Placebo Comparator		Other: Elental

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Elental	Other	200Kcal/200mL of liquid nutrient for 15 min at 7:30 am is administered in PEG patients	Elemental diet Liquid nutrient

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	Four hours (from 7:30 am to 11:30 am)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

percutaneous endoscopic gastrostomy patients

Exclusion Criteria:

history of abdominal surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Showa Inan General Hospital		Komagane	Nagano	399-4117	Japan