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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Postprocedural Delayed Gastric Emptying | Other: Elental | Not Applicable |
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 |
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
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Placebo Comparator: Liquid nutrient |
Other: Elental
200Kcal/200mL of liquid nutrient for 15 min at 7:30 am is administered in PEG patients
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- 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

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- percutaneous endoscopic gastrostomy patients
Exclusion Criteria:
- history of abdominal surgery

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
Japan | |
Showa Inan General Hospital | |
Komagane, Nagano, Japan, 399-4117 |
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 |