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

NCT03163355 | Completed

• 1 other identifier: 2017VE
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Swallowing Disorder

Keywords

pureed diet; dysphasia

Outcome Measures

Primary Outcomes (1)

• The pharyngeal clearance score (1-5)

  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.

  24 months

Secondary Outcomes (1)

• Patient feeling regarding pharyngeal clearance

  24 months

Study Arms (2)

pureed rice with a gelling agent

ACTIVE COMPARATOR

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

Other: a gelling agent

standard pureed rice

PLACEBO COMPARATOR

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

Other: a gelling agent

Interventions

a gelling agent OTHER

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.

pureed rice with a gelling agent; standard pureed rice

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Showa Inan General Hospital: lead

Study Sites (1)

Showa Inan General hospital

Komagane, Nagano, 399-4117, Japan

Location

MeSH Terms

Conditions

Deglutition Disorders; Aphasia

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Akira Horiuchi, MD

  Showa Inan General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Digestive Disease Center

Study Record Dates

• First Submitted: May 20, 2017
• First Posted: May 23, 2017
• Study Start: May 1, 2017
• Primary Completion: August 21, 2018
• Study Completion: September 4, 2018
• Last Updated: September 6, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)