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
  Purpose

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.


Condition Intervention
Postprocedural Delayed Gastric Emptying
Other: Elental

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Comparative Study of Elemental Diet and Regular Liquid Diet on Gastric Emptying in Patients With Percutaneous Endoscopic Gastrostomy

Further study details as provided by Showa Inan General Hospital:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 20
Study Start Date: November 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Elemental diet Other: Elental
200Kcal/200mL of liquid nutrient for 15 min at 7:30 am is administered in PEG patients
Placebo Comparator: Liquid nutrient Other: Elental
200Kcal/200mL of liquid nutrient for 15 min at 7:30 am is administered in PEG patients

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • percutaneous endoscopic gastrostomy patients

Exclusion Criteria:

  • history of abdominal surgery
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01467765

Locations
Japan
Showa Inan General Hospital
Komagane, Nagano, Japan, 399-4117
Sponsors and Collaborators
Showa Inan General Hospital
  More Information

No publications provided

Responsible Party: Akira Horiuchi, Chief, Digestive Disease Center, Showa Inan General Hospital
ClinicalTrials.gov Identifier: NCT01467765     History of Changes
Other Study ID Numbers: Elental study
Study First Received: November 5, 2011
Last Updated: August 7, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Gastroparesis
Digestive System Diseases
Gastrointestinal Diseases
Neurologic Manifestations
Paralysis
Signs and Symptoms
Stomach Diseases

ClinicalTrials.gov processed this record on October 29, 2014