The Effect of Elemental Diet on Gastric Emptying

Postprocedural Delayed Gastric Emptying Clinical Trial

— Elental  

Official title:

The Comparative Study of Elemental Diet and Regular Liquid Diet on Gastric Emptying in Patients With Percutaneous Endoscopic Gastrostomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01467765
• Other study ID #: Elental study
• Status: Completed
• Phase: N/A
• First received: November 5, 2011
• Last updated: August 7, 2012
• Start date: November 2011
• Est. completion date: April 2012

Study information

• Verified date: August 2012
• Source: Showa Inan General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• percutaneous endoscopic gastrostomy patients

Exclusion Criteria:

• history of abdominal surgery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroparesis
• Postprocedural Delayed Gastric Emptying

Intervention

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

Locations

Country	Name	City	State
Japan	Showa Inan General Hospital	Komagane	Nagano

Sponsors (1)

Lead Sponsor	Collaborator
Showa Inan General Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No