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The Effect of Elemental Diet on Gastric Emptying (Elental)

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ClinicalTrials.gov Identifier: NCT01467765
Recruitment Status : Completed
First Posted : November 9, 2011
Last Update Posted : August 9, 2012
Sponsor:
Information provided by (Responsible Party):
Akira Horiuchi, Showa Inan General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Postprocedural Delayed Gastric Emptying Other: Elental Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (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
Study Start Date : November 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

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Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Measurement of gastric emptying [ Time Frame: Four hours (from 7:30 am to 11:30 am) ]
    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


Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • percutaneous endoscopic gastrostomy patients

Exclusion Criteria:

  • history of abdominal surgery
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01467765


Locations
Japan
Showa Inan General Hospital
Komagane, Nagano, Japan, 399-4117
Sponsors and Collaborators
Showa Inan General Hospital
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted: November 9, 2011    Key Record Dates
Last Update Posted: August 9, 2012
Last Verified: August 2012

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