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NCT Number: NCT03163355

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

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.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Showa Inan General hospital

Komagane, Nagano, 399-4117, Japan

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. The pharyngeal clearance score (1-5)

    Time frame: 24 months

    • 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 outcomes

  1. Patient feeling regarding pharyngeal clearance

    Time frame: 24 months

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

Sponsors and collaborators

Lead sponsor

Showa Inan General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 23, 2017
Registry last updated
Sep 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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