Swallowing DisorderNCT03163355
Comparison of Pureed Rice Using a Gelling Agent and Standard Pureed Rice
A study testing a gelling agent in people with Swallowing Disorder, run by Showa Inan General Hospital at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Swallowing Disorder
- What is being tested?
- a gelling agent
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteJapan
- Study dates
- 1 May 2017to 4 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- hospitalized patients who underwent endoscopic swallowing evaluation at Showa Inan General Hospital
Who cannot join
- an age less than 65 years old or the presence of an acute infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- 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)
- Conditions
- Swallowing Disorder
- Being tested
- a gelling agent
- Keywords
- pureed diet, dysphasia
- Medical subject headings
- Deglutition Disorders, Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a gelling agentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: a gelling agent |
| standard pureed rice | Placebo comparator | 3 ml of standard pureed rice is attempted to swallow under endoscopic examination of swallowing Receives: Other: a gelling agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (1)
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)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start1 May 2017
- Primary completion21 Aug 2018
- Study completion4 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Swallowing DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Showa Inan General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akira Horiuchi, Showa Inan General Hospital
- Investigators
- Akira Horiuchi, MD, Principal investigator, Showa Inan General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03163355
- Sponsor's protocol ID
- 2017VE
- Status last verified
- Sep 2018
- First submitted
- 20 May 2017
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pureed Rice Using a Gelling Agent and Standard Pureed Rice in Swallowing in Elderly Patients With Dysphagia
- ClinicalTrials.gov ID
- NCT03163355
- Acronym / sponsor ID
- 2017VE
- Conditions
- Swallowing Disorder
- Keywords
- pureed diet, dysphasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Showa Inan General HospitalUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 21 Aug 2018 (actual)
- Study completion
- 4 Sep 2018 (actual)
- First posted
- 23 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pureed rice with a gelling agent | Active comparator | Other: a gelling agent3 ml of pureed rice containing a gelling agent is attempted to swallow under endoscopic examination of swallowing |
| standard pureed rice | Placebo comparator | Other: a gelling agent3 ml of standard pureed rice is attempted to swallow under endoscopic examination of swallowing |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- hospitalized patients who underwent endoscopic swallowing evaluation at Showa Inan General Hospital
Key exclusion criteria (1 listed)
- an age less than 65 years old or the presence of an acute infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a gelling agentPureed rice containing a gelling agent (Softia U, Nutri Co., Ltd., Yokkaichi, Japan) is compared with the standard purred rice in the condition of swallowing. | Other | pureed rice with a gelling agent, standard pureed rice |
Primary outcome
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.
1 secondary outcome
Patient feeling regarding pharyngeal clearance
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Akira Horiuchi, MD principal investigator
Showa Inan General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a gelling agent in people with Swallowing Disorder, run by Showa Inan General Hospital at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The pharyngeal clearance score (1-5) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2018.