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

Comparison of Pureed Rice Using a Gelling Agent and Standard Pureed Rice in Swallowing in Elderly Patients With Dysphagia

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.

Study Overview

• Status: Completed
• Conditions: Swallowing Disorder
• Intervention / Treatment: Other: a gelling agent

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:

1. No remains
2. Pharyngeal clearance is obtained after swallowing of test jelly once
3. Pharyngeal clearance is obtained after swallowing of test jelly twice
4. Pharyngeal clearance is obtained after swallowing of test jelly three times and more
5. 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)

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: pureed rice with a gelling agent; 3 ml of pureed rice containing a gelling agent is attempted to swallow under endoscopic examination of swallowing	Other: a gelling agent; 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.
Placebo Comparator: standard pureed rice; 3 ml of standard pureed rice is attempted to swallow under endoscopic examination of swallowing	Other: a gelling agent; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	24 months

Collaborators and Investigators

• Sponsor: Showa Inan General Hospital
• Investigators: Principal Investigator: Akira Horiuchi, MD, Showa Inan General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): August 21, 2018
• Study Completion (Actual): September 4, 2018

Study Registration Dates

• First Submitted: May 20, 2017
• First Submitted That Met QC Criteria: May 20, 2017
• First Posted (Actual): May 23, 2017

Study Record Updates

• Last Update Posted (Actual): September 6, 2018
• Last Update Submitted That Met QC Criteria: September 4, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: pureed diet; dysphasia
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: 2017VE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No