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Elemental Diets vs. Semi-solid Diets on Gastric Excretion and Gastroesophageal Regurgitation

Primary Purpose

Gastro-oesophageal Reflux

Status
Withdrawn
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Elmental diet
Semi-solid diet
Sponsored by
Showa Inan General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastro-oesophageal Reflux focused on measuring Elemental diet, semi-solid diet, gastric emptying, GER, PEG

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Bedridden PEG patients are admitted for fever which is the most common reason for admission of PEG patients to our hospital.

Exclusion Criteria:

  • Regular use of gastric acid blockers, motility drugs, benzodiazepines or opioids, any clinical evidence of acute infection, a history of abdominal surgery, and an American Society of Anesthesiologists physical status of class IV or V.

Sites / Locations

  • Showa Inan General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Elemental diet

Semi-solid diet

Arm Description

Study 1: Elemental diet (300 kcal/300 ml) containing a contrast medium (5 ml) is administered within 15 min using the PEG. Study 2: Elemental diet (200 kcal/200 mL) labeled with 100 mg [13C]sodium acetate is administered within 15 min using the PEG.

Study 1: Semi-solid diet (300 kcal/300 ml) containing a contrast medium (5 ml) is administered within 15 min using the PEG. Study 2: Semi-solid diet (200 kcal/200 mL) labeled with 100 mg [13C]sodium acetate is administered within 15 min using the PEG.

Outcomes

Primary Outcome Measures

Gastroesophageal regurgitation
The distribution of the administered diets is assessed at the distal esophagus, proximal and distal stomach using a plain CT before and 1 hour after the administration.

Secondary Outcome Measures

Gastric excretion
13C breath tests were performed to estimate gastric excretion.

Full Information

First Posted
November 2, 2014
Last Updated
October 30, 2015
Sponsor
Showa Inan General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02290626
Brief Title
Elemental Diets vs. Semi-solid Diets on Gastric Excretion and Gastroesophageal Regurgitation
Official Title
Randomized Comparison of Elemental Diets and Semi-solid Diets on Gastric Excretion and Gastroesophageal Regurgitation in Bedridden Gastrostomy-fed Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Study protocol was changed.
Study Start Date
November 2014 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
March 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Showa Inan General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Study 1: A randomized, crossover trial using elemental or semi-solid diets containing contrast medium as a tracer given to bedridden PEG patients. The distribution of the administered diets is assessed at the distal esophagus, proximal and distal stomach using a plain CT before and 1 hour after the administration. Study 2: A randomized, crossover trial using elemental or semi-solid diets containing 13C sodium acetate as a tracer given to bedridden PEG patients. 13C breath tests are performed to estimate gastric emptying.
Detailed Description
Study 1: A mix of elemental or semi-solid diet (300 kcal/300 mL ) and contrast medium (5ml) is administered using PEG, respectively. Using a plain CT, the distribution of the administered diet is assessed at the distal esophagus, proximal and distal stomach before and 1 hour after the administration. The volume of the residual diet at the distal esophagus, proximal and distal stomach is compared between an elemental and semi-solid diet. Study 2: Either the elemental diet or semi-solid diet (200 kcal/200 mL) is labeled with 100 mg [13C]sodium acetate (Cambridge Isotope Laboratories Inc, Cambridge, MA) and is administered in the first 15 min of the examination at the same speed using the PEG.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro-oesophageal Reflux
Keywords
Elemental diet, semi-solid diet, gastric emptying, GER, PEG

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elemental diet
Arm Type
Experimental
Arm Description
Study 1: Elemental diet (300 kcal/300 ml) containing a contrast medium (5 ml) is administered within 15 min using the PEG. Study 2: Elemental diet (200 kcal/200 mL) labeled with 100 mg [13C]sodium acetate is administered within 15 min using the PEG.
Arm Title
Semi-solid diet
Arm Type
Active Comparator
Arm Description
Study 1: Semi-solid diet (300 kcal/300 ml) containing a contrast medium (5 ml) is administered within 15 min using the PEG. Study 2: Semi-solid diet (200 kcal/200 mL) labeled with 100 mg [13C]sodium acetate is administered within 15 min using the PEG.
Intervention Type
Drug
Intervention Name(s)
Elmental diet
Other Intervention Name(s)
Elental
Intervention Description
elemental diet is administered using PEG.
Intervention Type
Drug
Intervention Name(s)
Semi-solid diet
Other Intervention Name(s)
Racol-NF semisolid
Intervention Description
Semi-solid diet is administered using PEG.
Primary Outcome Measure Information:
Title
Gastroesophageal regurgitation
Description
The distribution of the administered diets is assessed at the distal esophagus, proximal and distal stomach using a plain CT before and 1 hour after the administration.
Time Frame
A half year
Secondary Outcome Measure Information:
Title
Gastric excretion
Description
13C breath tests were performed to estimate gastric excretion.
Time Frame
A half year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Bedridden PEG patients are admitted for fever which is the most common reason for admission of PEG patients to our hospital. Exclusion Criteria: Regular use of gastric acid blockers, motility drugs, benzodiazepines or opioids, any clinical evidence of acute infection, a history of abdominal surgery, and an American Society of Anesthesiologists physical status of class IV or V.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akira Horiuchi, MD
Organizational Affiliation
Showa Inan General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Showa Inan General Hospital
City
Komagane
ZIP/Postal Code
399-4191
Country
Japan

12. IPD Sharing Statement

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Elemental Diets vs. Semi-solid Diets on Gastric Excretion and Gastroesophageal Regurgitation

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