Dose-response Effect of the Thickener Tsururinko Quickly

NCT04565587 | Unknown

• 1 other identifier: TQUICKLY
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dysphagia; Dysphagia, Oral Phase; Dysphagia, Oropharyngeal; Dysphagia, Esophageal; Swallowing Disorder

Keywords

thickener; rheology; dysphagia; dose-response effect; salivary amylase effect; shear rate

Outcome Measures

Primary Outcomes (1)

• 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)

  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)

  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)

  2 days

• Assess the effect of oral incubation with salivary amylase on Tsururinko Quickly

  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)

  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)

  2 days

Study Arms (1)

Videofluoroscopy

OTHER

All participants will undergo a Videofluoroscopy when swallowing different viscosity levels of the thickener Tsururinko Quickly (japanese thickener)

Other: Xanthan-gum based thickener

Interventions

Xanthan-gum based thickener OTHER

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.

Also known as: Alimentary thickener

Videofluoroscopy

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥70 years
• Oropharyngeal Dysphagia: clinical signs or symptoms of swallowing dysfunction (safety or efficacy impairments), based on videofluoroscopy (VFS)
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Morinaga Milk Industry Co., LTD: lead
• Hospital de Mataró: collaborator

Study Sites (1)

Hospital de Mataró

Mataró, 08304, Spain

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Pere Clavé, MD

  Hospital de Mataró

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mireia Bolívar-Prados, Pharmacy

CONTACT

0034 937417700; mbolivar@csdm.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Analyisis of the therapeutic effect of the viscosities will be performed in a codified manner by a researcher.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All the participants will be assigned to the same intervention.

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: September 25, 2020
• Study Start: August 5, 2020
• Primary Completion: May 1, 2022
• Study Completion: August 1, 2022
• Last Updated: September 9, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)