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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03163355
Recruitment Status : Completed
First Posted : May 23, 2017
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Akira Horiuchi, Showa Inan General Hospital

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.

Condition or disease Intervention/treatment Phase
Swallowing Disorder Other: a gelling agent Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Comparison of Pureed Rice Using a Gelling Agent and Standard Pureed Rice in Swallowing in Elderly Patients With Dysphagia
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : August 21, 2018
Actual Study Completion Date : September 4, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. The pharyngeal clearance score (1-5) [ Time Frame: 24 months ]
    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.


Secondary Outcome Measures :
  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)



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03163355


Locations
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Japan
Showa Inan General hospital
Komagane, Nagano, Japan, 399-4117
Sponsors and Collaborators
Showa Inan General Hospital
Investigators
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Principal Investigator: Akira Horiuchi, MD Showa Inan General Hospital

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Responsible Party: Akira Horiuchi, Chief of Digestive Disease Center, Showa Inan General Hospital
ClinicalTrials.gov Identifier: NCT03163355    
Other Study ID Numbers: 2017VE
First Posted: May 23, 2017    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Akira Horiuchi, Showa Inan General Hospital:
pureed diet
dysphasia
Additional relevant MeSH terms:
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Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases