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Comparison of Pureed Rice Using a Gelling Agent and Standard Pureed Rice

Primary Purpose

Swallowing Disorder

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
a gelling agent
Sponsored by
Showa Inan General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Swallowing Disorder focused on measuring pureed diet, dysphasia

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • hospitalized patients who underwent endoscopic swallowing evaluation at Showa Inan General Hospital

Exclusion Criteria:

  • an age less than 65 years old or the presence of an acute infection.

Sites / Locations

  • Showa Inan General hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

pureed rice with a gelling agent

standard pureed rice

Arm Description

3 ml of pureed rice containing a gelling agent is attempted to swallow under endoscopic examination of swallowing

3 ml of standard pureed rice is attempted to swallow under endoscopic examination of swallowing

Outcomes

Primary Outcome Measures

The pharyngeal clearance score (1-5)
No remains Pharyngeal clearance is obtained after swallowing of test jelly once Pharyngeal clearance is obtained after swallowing of test jelly twice Pharyngeal clearance is obtained after swallowing of test jelly three times and more In spite of swallowing of test jelly, pharyngeal residues remain and/or penetrate into larynx.

Secondary Outcome Measures

Patient feeling regarding pharyngeal clearance
Patient feeling regarding pharyngeal clearance after the swallowing of pureed rice and/or test jelly (0 remains -100% complete clearance)

Full Information

First Posted
May 20, 2017
Last Updated
September 4, 2018
Sponsor
Showa Inan General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03163355
Brief Title
Comparison of Pureed Rice Using a Gelling Agent and Standard Pureed Rice
Official Title
Comparison of Pureed Rice Using a Gelling Agent and Standard Pureed Rice in Swallowing in Elderly Patients With Dysphagia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
August 21, 2018 (Actual)
Study Completion Date
September 4, 2018 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The texture of the pureed diet is likely to be most useful factor predictive of the prevention of aspiration pneumonia. However, it has not been previously reported what kinds of texture of the pureed diet can prevent aspiration pneumonia. Using endoscopic swallowing evaluation, we attempt to compare two kinds of the pureed diets to choose the better texture of pureed diets in elderly patients with severe dysphagia.
Detailed Description
The degree of dysphagia is evaluated using Hyodo.Komagane score (0-12). Subsequently, a randomized, crossover trial using pureed rice containing a gelling agent (Softia U, Nutri Co., Ltd., Yokkaichi, Japan), or standard pureed rice is performed in patients with dysphagia. The extent of pharyngeal clearance after swallowing of each pureed rice and test jelly (Isotonic green jelly®, Nutri Co., Ltd., Yokkaichi, Japan) is scored as follows: No remains Pharyngeal clearance is obtained after swallowing of test jelly once Pharyngeal clearance is obtained after swallowing of test jelly twice Pharyngeal clearance is obtained after swallowing of test jelly three times and more In spite of swallowing of test jelly, pharyngeal residues remain and/or penetrate into larynx. Evaluation Primary outcome: The pharyngeal clearance score (1-5) Secondary outcome: Patient feeling regarding pharyngeal clearance after the swallowing of pureed rice and/or test jelly (0 remains -100% complete clearance)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Swallowing Disorder
Keywords
pureed diet, dysphasia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pureed rice with a gelling agent
Arm Type
Active Comparator
Arm Description
3 ml of pureed rice containing a gelling agent is attempted to swallow under endoscopic examination of swallowing
Arm Title
standard pureed rice
Arm Type
Placebo Comparator
Arm Description
3 ml of standard pureed rice is attempted to swallow under endoscopic examination of swallowing
Intervention Type
Other
Intervention Name(s)
a gelling agent
Intervention Description
Pureed rice containing a gelling agent (Softia U, Nutri Co., Ltd., Yokkaichi, Japan) is compared with the standard purred rice in the condition of swallowing.
Primary Outcome Measure Information:
Title
The pharyngeal clearance score (1-5)
Description
No remains Pharyngeal clearance is obtained after swallowing of test jelly once Pharyngeal clearance is obtained after swallowing of test jelly twice Pharyngeal clearance is obtained after swallowing of test jelly three times and more In spite of swallowing of test jelly, pharyngeal residues remain and/or penetrate into larynx.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Patient feeling regarding pharyngeal clearance
Description
Patient feeling regarding pharyngeal clearance after the swallowing of pureed rice and/or test jelly (0 remains -100% complete clearance)
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: hospitalized patients who underwent endoscopic swallowing evaluation at Showa Inan General Hospital Exclusion Criteria: an age less than 65 years old or the presence of an acute infection.
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
State/Province
Nagano
ZIP/Postal Code
399-4117
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Pureed Rice Using a Gelling Agent and Standard Pureed Rice

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