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

Swallowing Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03163355
• Other study ID #: 2017VE
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: September 4, 2018

Study information

• Verified date: September 2018
• Source: Showa Inan General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 4, 2018
• Est. primary completion date: August 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deglutition Disorders
• Swallowing Disorder

Intervention

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.

Locations

Country	Name	City	State
Japan	Showa Inan General hospital	Komagane	Nagano

Sponsors (1)

Lead Sponsor	Collaborator
Showa Inan General Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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