NCT01467765

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 9, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

August 9, 2012

Status Verified

August 1, 2012

Enrollment Period

5 months

First QC Date

November 5, 2011

Last Update Submit

August 7, 2012

Conditions

Postprocedural Delayed Gastric Emptying

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (2)

Elemental diet

ACTIVE COMPARATOR
Other: Elental

Liquid nutrient

PLACEBO COMPARATOR
Other: Elental

Interventions

ElentalOTHER

200Kcal/200mL of liquid nutrient for 15 min at 7:30 am is administered in PEG patients

Elemental dietLiquid nutrient

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • percutaneous endoscopic gastrostomy patients

You may not qualify if:

  • history of abdominal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Showa Inan General Hospital

Komagane, Nagano, 399-4117, Japan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Digestive Disease Center

Study Record Dates

First Submitted

November 5, 2011

First Posted

November 9, 2011

Study Start

November 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

August 9, 2012

Record last verified: 2012-08

Locations

JP(1)