Dysphagia58/19NCT04565587
Dose-response Effect of the Thickener Tsururinko Quickly
A study testing Xanthan-gum based thickener in people with Dysphagia and Dysphagia, Oral Phase, run by Morinaga Milk Industry Co., LTD at 1 site in Spain.
Trial summary
Thickening fluids are a valid therapeutic strategy to improve safe swallowing in OD. The aim of this study is to assess the percentage of safe swallowing at different viscosity levels thickened with Tsururinko Quickly. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Dysphagia, Dysphagia, Oral Phase, Dysphagia, Oropharyngeal
- What is being tested?
- Xanthan-gum based thickener
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 5 Aug 2020to Aug 2022
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥70 years
- Oropharyngeal Dysphagia: clinical signs or symptoms of swallowing dysfunction (safety or efficacy impairments), based on videofluoroscopy (VFS)
- Written informed consent
Who cannot join
- No clinical signs or symptoms of swallowing dysfunction, based on videofluoroscopy (VFS)
- OD due to structural alterations
- Severe cognitive disorders or Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements and instructions
- Not able to undergo VFS due to incapability of sitting posture
- Pregnancy and/or lactating
- Allergy to any ingredient of test product or iodine products
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de Mataró
Mataró, 08304
Mireia Bolívar-Prados, Pharmacy, 0034 937417700 ext. 2285, mbolivar@csdm.cat
Mireia Bolívar-Prados, Pharmacy
About this study
Official title: Rheological Characterization of the Thickener Tsururinko Quickly and Dose-response Effect on Older Patients
Thickening fluids are a valid therapeutic strategy to improve safe swallowing in OD. The aim of this study is to assess the percentage of safe swallowing at different viscosity levels thickened with Tsururinko Quickly.
This study is designed to assess the therapeutic effect on safety and efficacy of swallow of Tsururinko Quickly for the levels of viscosity 100, 200, 400, 800, 1600mPa·s against thin liquid and between all the viscosity levels in older patients with Oropharyngeal Dysphagia (OD) by performing a Videofluoroscopy when swallowing. As all patients will start with thin liquid, each patient will be its own control. To analyze the effect of the salivary amylase on the thickener, participants will be asked to maintain two boluses (200 and 800mPa·s) prepared jut with mineral water in the oral cavity for 30seconds. After that period, boluses will be analyzed by a viscometer and compared to those without oral incubation.
Read the detailed description
Older patients, who fulfil the eligibility criteria, are invited to participate in the study. After having signed informed consent, participants who meet the inclusion and exclusion criteria will a screening procedure (V-VST). Viscosities for the V-VST: <50, 200mPa·s and 800mPa·s. Two questions will be performed to the patient on palatability and acceptability. Palatability will be assessed by the 5-points hedonic scale and acceptability with the Scorecard - Food Action Rating Test. After it, a Videofluoroscopy (VFS) will be performed. For the VFS, participants will swallow 10mL boluses (by duplicate) of thin liquid and 5 different thickened viscosities of Tsururinko Quickly (1600, 800, 400, 200 and 100 mPa·s) with a stablished safety rule: when the subject aspirates at the first bolus of thin liquid, the second volume will not be given and the measurements will continue with the thickened varieties to the thinnest viscosity. In case the subject aspirates at one thickened bolus, the VFS ends for this specific patient. As all patients will start with thin liquid, each patient will be its own control with the non-thickened viscosity vs the others in order to establish the safety of swallow for all the levels performed. Patient's swallow will be studied with VFS in a lateral projection and images will include the oral cavity, pharynx, larynx and cervical oesophagus. After each bolus, the patient will be asked to give their opinion on the palatability of this specific bolus.
Before VFS, a bolus of 200 and 800mPa·s (without contrast) will be given to the participant in order to perform the oral incubation analysis. Participants should keep the bolus in their mouth for 30" and then spit it out. The bolus is then analysed with the viscometer at the shear rate of 50s-1 (estimated value at the oral cavity) and 300s-1 (estimated value at the pharynx). Viscosity values will be compared to the viscosity values without oral incubation. The day after the completion of the VFS participants will be asked by phone for AE.
- Conditions
- Dysphagia, Dysphagia, Oral Phase, Dysphagia, Oropharyngeal, Dysphagia, Esophageal, Swallowing Disorder
- Being tested
- Xanthan-gum based thickener
- Keywords
- thickener, rheology, dysphagia, dose-response effect, salivary amylase effect, shear rate
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xanthan-gum based thickenerOther
Also called Alimentary thickener
Participants will undergo a screening procedure (V-VST) with two of the viscosities levels determined and prepared with mineral water and Tsururinko Quickly (200 and 800mPa·s). After the V-VST, a Videofluoroscopy (VFS) will be performed with thin liquid and 5 viscosity levels prepared with X-Ray contrast (Omnipaque), mineral water and Tsururinko Quickly (100, 200, 400, 800, 1600mPa·s). Participants swallow will be studied with VFS in a lateral projection and images will include the oral cavity, pharynx, larynx and cervical oesophagus. Swallows will be analysed by equipment developed to capture and digitize the swallowing sequences to assess VFS signs of safety and efficacy according to accepted definitions and to measure the timing and spatial events of the swallow response.
| Study group | Role | What they receive |
|---|---|---|
| Videofluoroscopy | Other | All participants will undergo a Videofluoroscopy when swallowing different viscosity levels of the thickener Tsururinko Quickly (japanese thickener) Receives: Other: Xanthan-gum based thickener |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic effect on safety and efficacy of swallow of Tsururinko Quickly for the levels of viscosity 100, 200, 400, 800, 1600mPa·s against thin liquid and within each viscosity in older patients with Oropharyngeal Dysphagia (OD)
Percentage of participants that swallow safely (PAS score 1, 2) for each viscosity level (Rosenbek, 1996)
Measured: 2 days
Secondary outcomes (5)
Safety of swallowing for the levels of viscosity 100, 200, 400, 800, 1600mPa·s against thin liquid and within each viscosity in older patients with Oropharyngeal Dysphagia (OD)
Safety of swallowing measured by mean PAS score, percentage of patients with safe swallowing (PAS1, 2), percentage of patients with penetration (PAS score 3, 4, 5) and percentage of patients with aspiration (PAS score 6, 7, 8)
Measured: 2 days
Efficacy of swallowing for the levels of viscosity 100, 200, 400, 800, 1600mPa·s against thin liquid and within each viscosity in older patients with Oropharyngeal Dysphagia (OD)
Efficacy of swallowing expressed by prevalence and severity of patients with oral and pharyngeal residue assessed by the scale defined by Robbins et al. 2007
Measured: 2 days
Assess the effect of oral incubation with salivary amylase on Tsururinko Quickly
To assess the resistance of the product to the α-salivary amylase by the viscosity decrease (%)
Measured: 2 days
Physiology of swallowing for the levels of viscosity 100, 200, 400, 800, 1600mPa·s against thin liquid and within each viscosity in older patients with Oropharyngeal Dysphagia (OD)
Swallowing physiology assessed as time to laryngeal vestibule closure (LVC) (ms), time to laryngeal vestibule opening (ms), total duration of swallowing response (ms), time to upper oesophageal sphincter opening (UESO) (ms) and bolus velocity (m/s),
Measured: 2 days
Kinematics of the bolus while swallowing for the levels of viscosity 100, 200, 400, 800, 1600mPa·s against thin liquid and within each viscosity in older patients with Oropharyngeal Dysphagia (OD)
Kinematics of the bolus assessed as translational kinetic energy (KE; MJ) prior to entering the UES.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start5 Aug 2020
- Primary completionMay 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All the participants will be assigned to the same intervention.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Morinaga Milk Industry Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital de Mataró
- Responsible party
- Sponsor
- Investigators
- Pere Clavé, MD, Principal investigator, Hospital de Mataró
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04565587
- Sponsor's protocol ID
- TQUICKLY
- Acronym
- 58/19
- Status last verified
- Sep 2021
- First submitted
- 25 Aug 2020
- Last updated
- 9 Sep 2021
- 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 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rheological Characterization of the Thickener Tsururinko Quickly and Dose-response Effect on Older Patients
- ClinicalTrials.gov ID
- NCT04565587
- Acronym / sponsor ID
- 58/19 / TQUICKLY
- Conditions
- Dysphagia, Dysphagia, Oral Phase, Dysphagia, Oropharyngeal, Dysphagia, Esophageal, Swallowing Disorder
- Keywords
- thickener, rheology, dysphagia, dose-response effect, salivary amylase effect, shear rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Morinaga Milk Industry Co., LTDIndustry (pharma, biotech, devices)
- Collaborators
- Hospital de Mataró
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 25 Sep 2020 (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.
Thickening fluids are a valid therapeutic strategy to improve safe swallowing in OD. The aim of this study is to assess the percentage of safe swallowing at different viscosity levels thickened with Tsururinko Quickly.
This study is designed to assess the therapeutic effect on safety and efficacy of swallow of Tsururinko Quickly for the levels of viscosity 100, 200, 400, 800, 1600mPa·s against thin liquid and between all the viscosity levels in older patients with Oropharyngeal Dysphagia (OD) by performing a Videofluoroscopy when swallowing. As all patients will start with thin liquid, each patient will be its own control. To analyze the effect of the salivary amylase on the thickener, participants will be asked to maintain two boluses (200 and 800mPa·s) prepared jut with mineral water in the oral cavity for 30seconds. After that period, boluses will be analyzed by a viscometer and compared to those without oral incubation.
Detailed description
Older patients, who fulfil the eligibility criteria, are invited to participate in the study. After having signed informed consent, participants who meet the inclusion and exclusion criteria will a screening procedure (V-VST). Viscosities for the V-VST: <50, 200mPa·s and 800mPa·s. Two questions will be performed to the patient on palatability and acceptability. Palatability will be assessed by the 5-points hedonic scale and acceptability with the Scorecard - Food Action Rating Test. After it, a Videofluoroscopy (VFS) will be performed. For the VFS, participants will swallow 10mL boluses (by duplicate) of thin liquid and 5 different thickened viscosities of Tsururinko Quickly (1600, 800, 400, 200 and 100 mPa·s) with a stablished safety rule: when the subject aspirates at the first bolus of thin liquid, the second volume will not be given and the measurements will continue with the thickened varieties to the thinnest viscosity. In case the subject aspirates at one thickened bolus, the VFS ends for this specific patient. As all patients will start with thin liquid, each patient will be its own control with the non-thickened viscosity vs the others in order to establish the safety of swallow for all the levels performed. Patient's swallow will be studied with VFS in a lateral projection and images will include the oral cavity, pharynx, larynx and cervical oesophagus. After each bolus, the patient will be asked to give their opinion on the palatability of this specific bolus.
Before VFS, a bolus of 200 and 800mPa·s (without contrast) will be given to the participant in order to perform the oral incubation analysis. Participants should keep the bolus in their mouth for 30" and then spit it out. The bolus is then analysed with the viscometer at the shear rate of 50s-1 (estimated value at the oral cavity) and 300s-1 (estimated value at the pharynx). Viscosity values will be compared to the viscosity values without oral incubation. The day after the completion of the VFS participants will be asked by phone for AE.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All the participants will be assigned to the same intervention.
| Arm | Type | Receives |
|---|---|---|
| Videofluoroscopy | Other | Other: Xanthan-gum based thickenerAll participants will undergo a Videofluoroscopy when swallowing different viscosity levels of the thickener Tsururinko Quickly (japanese thickener) |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age ≥70 years
- Oropharyngeal Dysphagia: clinical signs or symptoms of swallowing dysfunction (safety or efficacy impairments), based on videofluoroscopy (VFS)
- Written informed consent
Key exclusion criteria (6 listed)
- No clinical signs or symptoms of swallowing dysfunction, based on videofluoroscopy (VFS)
- OD due to structural alterations
- Severe cognitive disorders or Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements and instructions
- Not able to undergo VFS due to incapability of sitting posture
- Pregnancy and/or lactating
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 |
|---|---|---|
| Xanthan-gum based thickenerAlso: Alimentary thickenerParticipants will undergo a screening procedure (V-VST) with two of the viscosities levels determined and prepared with mineral water and Tsururinko Quickly (200 and 800mPa·s). After the V-VST, a Videofluoroscopy (VFS) will be performed with thin liquid and 5 viscosity levels prepared with X-Ray contrast (Omnipaque), mineral water and Tsururinko Quickly (100, 200, 400, 800, 1600mPa·s). Participants swallow will be studied with VFS in a lateral projection and images will include the oral cavity, pharynx, larynx and cervical oesophagus. Swallows will be analysed by equipment developed to capture and digitize the swallowing sequences to assess VFS signs of safety and efficacy according to accepted definitions and to measure the timing and spatial events of the swallow response. | Other | Videofluoroscopy |
Primary outcome
Therapeutic effect on safety and efficacy of swallow of Tsururinko Quickly for the levels of viscosity 100, 200, 400, 800, 1600mPa·s against thin liquid and within each viscosity in older patients with Oropharyngeal Dysphagia (OD)
Time frame: 2 days
Percentage of participants that swallow safely (PAS score 1, 2) for each viscosity level (Rosenbek, 1996)
5 secondary outcomes
Safety of swallowing for the levels of viscosity 100, 200, 400, 800, 1600mPa·s against thin liquid and within each viscosity in older patients with Oropharyngeal Dysphagia (OD)
Time frame: 2 days
Efficacy of swallowing for the levels of viscosity 100, 200, 400, 800, 1600mPa·s against thin liquid and within each viscosity in older patients with Oropharyngeal Dysphagia (OD)
Time frame: 2 days
Assess the effect of oral incubation with salivary amylase on Tsururinko Quickly
Time frame: 2 days
Physiology of swallowing for the levels of viscosity 100, 200, 400, 800, 1600mPa·s against thin liquid and within each viscosity in older patients with Oropharyngeal Dysphagia (OD)
Time frame: 2 days
Kinematics of the bolus while swallowing for the levels of viscosity 100, 200, 400, 800, 1600mPa·s against thin liquid and within each viscosity in older patients with Oropharyngeal Dysphagia (OD)
Time frame: 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- 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.
Pere Clavé, MD principal investigator
Hospital de Mataró
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xanthan-gum based thickener in people with Dysphagia and Dysphagia, Oral Phase, run by Morinaga Milk Industry Co., LTD at 1 site in Spain.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 9 Sep 2021. 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 Spain. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mireia Bolívar-Prados, Pharmacy (0034 937417700 ext. 2285, mbolivar@csdm.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic effect on safety and efficacy of swallow of Tsururinko Quickly for the levels of viscosity 100, 200, 400, 800, 1600mPa·s against thin liquid and within each viscosity in older patients with Oropharyngeal Dysphagia (OD) (time frame: 2 days). 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 9 Sep 2021.