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The Effect of Elemental Diet on Gastric Emptying (Elental)
This study has been completed.
Sponsor:
Showa Inan General Hospital
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
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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 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 |
Further study details as provided by Akira Horiuchi, Showa Inan General Hospital:
Primary Outcome Measures:
- 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
| 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| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01467765
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
| 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 |
Additional relevant MeSH terms:
|
Gastroparesis Stomach Diseases Gastrointestinal Diseases Digestive System Diseases |
Paralysis Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on September 20, 2017