DysphagiaNCT02522351
Reduction of Aspiration Through Cohesive Thin Liquids (CTL) in Patients With Mild Oropharyngeal Dysphagia
A study testing Cereal extract concentration 1, Cereal extract concentration 2 and Cereal extract concentration 3 in people with Dysphagia and Stroke, run by Société des Produits Nestlé (SPN) at 2 sites in 2 countries.
Trial summary
The aim of the trial is to identify any systematic effect of cohesiveness on the efficacy of swallowing in patients having dysphagia problems. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- What is being tested?
- Cereal extract concentration 1, Cereal extract concentration 2 and Cereal extract concentration 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2015to Sep 2017
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild dysphagia as defined by a score between 3 and 5 on the Dysphagia Outcome and Severity Scale
- Patients aged between 18 and 85 years
- Ischemic/hemorrhagic cerebral cause (stroke)
- Able to understand French (oral and written)
- Cognitive capacity enough to understand study procedures
- Having health insurance (which in France is " social security")
- Having signed the consent form.
Who cannot join
- Any swallowing trouble not resulting from the current stroke
- History of inhalation pneumopathy, i.e. any pulmonary inflammation linked to the path of a solid or liquid food in the respiratory system
- Any physician diagnosed psychiatric illness
- Patient with a digestive fistula
- Any physician diagnosed food allergy
- Any known allergy to barium or any compound of the contrast product
Show all 11Show fewer
- Confirmed or suspected perforated and occlusive syndrome
- Pregnant or lactating women
- Major respiratory disease needing oxygen (chronic respiratory insufficiency)
- Subject who cannot be expected to comply with the study procedures, including consuming the test products.
- Currently participating or having participated in another clinical trial during the month preceding the study
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Reduction of Aspiration Through Cohesive Thin Liquids (CTL) in Patients With Mild Oropharyngeal Dysphagia Due to Ischemic/Hemorrhagic Cerebral Cause (Stroke)
The aim of the trial is to identify any systematic effect of cohesiveness on the efficacy of swallowing in patients having dysphagia problems.
Read the detailed description
This trial will be a double blind, randomized, crossover, controlled, and interventional trial. Each subject will test 6 study samples in a randomized order at 5 mL of volume first then at 10 mL (12 samples maximum). The trial will last a maximum of one hour (a single study visit).
The total sample size is 47 enrolled subjects, 33 subjects completed. Patients will be females and males aged between 18 and 85 years with mild proven dysphagia.
- Being tested
- Cereal extract concentration 1, Cereal extract concentration 2, Cereal extract concentration 3, Thicken up clear concentration 1, Thicken up clear concentration 2
- Medical subject headings
- Deglutition Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cereal extract concentration 1Other
Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem
Cereal extract concentration 2Other
Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem
Cereal extract concentration 3Other
Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem
Thicken up clear concentration 1Other
Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem
Thicken up clear concentration 2Other
Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem
Thicken up clear concentration 3Other
Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem
| Study group | Role | What they receive |
|---|---|---|
| Thicken Up Clear concentration 1 | Active comparator | Thicken Up Clear at concentration 1 Receives: Other: Cereal extract concentration 1; Other: Cereal extract concentration 2; Other: Cereal extract concentration 3; Other: Thicken up clear concentration 2; Other: Thicken up clear concentration 3 |
| Thicken Up Clear concentration 2 | Active comparator | Thicken Up Clear at concentration 2 Receives: Other: Cereal extract concentration 1; Other: Cereal extract concentration 2; Other: Cereal extract concentration 3; Other: Thicken up clear concentration 1; Other: Thicken up clear concentration 3 |
| Thicken Up Clear concentration 3 | Active comparator | Thicken Up Clear at concentration 3 Receives: Other: Cereal extract concentration 1; Other: Cereal extract concentration 2; Other: Cereal extract concentration 3; Other: Thicken up clear concentration 1; Other: Thicken up clear concentration 2 |
| Cereal extract concentration 1 | Experimental | Cereal extract at concentration 1 Receives: Other: Cereal extract concentration 2; Other: Cereal extract concentration 3; Other: Thicken up clear concentration 1; Other: Thicken up clear concentration 2; Other: Thicken up clear concentration 3 |
| Cereal extract concentration 2 | Experimental | Cereal extract at concentration 2 Receives: Other: Cereal extract concentration 1; Other: Cereal extract concentration 3; Other: Thicken up clear concentration 1; Other: Thicken up clear concentration 2; Other: Thicken up clear concentration 3 |
| Cereal extract concentration 3 | Experimental | Cereal extract at concentration 3 Receives: Other: Cereal extract concentration 1; Other: Cereal extract concentration 2; Other: Thicken up clear concentration 1; Other: Thicken up clear concentration 2; Other: Thicken up clear concentration 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of any systematic effect of cohesiveness on the efficacy of swallowing in dysphagic patients according to Rosenbek's Penetration-Aspiration Score (PAS) using videofluoroscopy
The PAS score across each bolus (5 mL and 10 mL)
Measured: During the ingestion (videofluoroscopy), maximum during one hour.
Secondary outcomes (11)
Swallowing safety- prevalence of penetration
The prevalence of penetration in the population according to Rosenbek's PAS (score of 2-5) assessed using videofluoroscopy
Measured: During the ingestion (videofluoroscopy), maximum during one hour.
Swallowing safety- prevalence of aspiration
The prevalence of aspiration in the population according to Rosenbek's PAS (score of 6-8) assessed using videofluoroscopy
Measured: During the ingestion (videofluoroscopy), maximum during one hour.
Swallowing function- Amount/volume of oral and pharyngeal residues
The amount/volume of oral and pharyngeal residues assessed using videofluoroscopy
Measured: During the ingestion (videofluoroscopy), maximum during one hour.
Swallowing function- Prevalence of subjects with oral and pharyngeal residues
The prevalence of subjects of oral and pharyngeal residues assessed using videofluoroscopy
Measured: During the ingestion (videofluoroscopy), maximum during one hour.
Swallowing function- Oral transit time (OTT, time between tongue tip elevation and arrival of the bolus at the ramus of the mandible)
Oral transit time (OTT, time between tongue tip elevation and arrival of the bolus at the ramus of the mandible)
Measured: During the ingestion (videofluoroscopy), maximum during one hour.
Swallowing function- Swallow response time (SRT, time between arrival of the bolus at the ramus of the mandible and pharyngeal phases of swallowing)
Swallow response time (SRT, time between arrival of the bolus at the ramus of the mandible and pharyngeal phases of swallowing)
Measured: During the ingestion (videofluoroscopy), maximum during one hour.
Swallowing function- Pharyngeal transit time (PTT, time between arrival of the bolus at the ramus of the mandible and the tail of the bolus passing through the upper esophageal sphincter)
Pharyngeal transit time (PTT, time between arrival of the bolus at the ramus of the mandible and the tail of the bolus passing through the upper esophageal sphincter)
Measured: During the ingestion (videofluoroscopy), maximum during one hour.
Swallowing function- Time to upper esophageal sphincter opening (UESO, time between tongue tip elevation and opening of the upper esophageal sphincter)
Time to upper esophageal sphincter opening (UESO, time between tongue tip elevation and opening of the upper esophageal sphincter)
Measured: During the ingestion (videofluoroscopy), maximum during one hour.
Swallowing function-Time to laryngeal vestibule opening (LVO, time between tongue tip elevation and pharyngeal phases of swallowing)
Time to laryngeal vestibule opening (LVO, time between tongue tip elevation and pharyngeal phases of swallowing)
Measured: During the ingestion (videofluoroscopy), maximum during one hour.
Swallowing function- Time to laryngeal vestibule closure (LVC, time between tongue tip elevation and maximal laryngeal closure)
Time to laryngeal vestibule closure (LVC, time between tongue tip elevation and maximal laryngeal closure)
Measured: During the ingestion (videofluoroscopy), maximum during one hour.
Subjective perception of ease of swallowing and oropharyngeal sensation.
This will be assessed from a questionnaire.
Measured: Right after ingredient ingestion, maximum during one hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2017
- Study completionSep 2017
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.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522351
- Sponsor's protocol ID
- 13.21. NRC
- Status last verified
- Oct 2017
- First submitted
- 13 Jul 2015
- Last updated
- 5 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Aspiration Through Cohesive Thin Liquids (CTL) in Patients With Mild Oropharyngeal Dysphagia Due to Ischemic/Hemorrhagic Cerebral Cause (Stroke)
- ClinicalTrials.gov ID
- NCT02522351
- Acronym / sponsor ID
- 13.21. NRC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Jun 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 13 Aug 2015 (estimated)
- 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 aim of the trial is to identify any systematic effect of cohesiveness on the efficacy of swallowing in patients having dysphagia problems.
Detailed description
This trial will be a double blind, randomized, crossover, controlled, and interventional trial. Each subject will test 6 study samples in a randomized order at 5 mL of volume first then at 10 mL (12 samples maximum). The trial will last a maximum of one hour (a single study visit).
The total sample size is 47 enrolled subjects, 33 subjects completed. Patients will be females and males aged between 18 and 85 years with mild proven dysphagia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Thicken Up Clear concentration 1 | Active comparator | Other: Cereal extract concentration 1, Other: Cereal extract concentration 2, Other: Cereal extract concentration 3, Other: Thicken up clear concentration 2, Other: Thicken up clear concentration 3Thicken Up Clear at concentration 1 |
| Thicken Up Clear concentration 2 | Active comparator | Other: Cereal extract concentration 1, Other: Cereal extract concentration 2, Other: Cereal extract concentration 3, Other: Thicken up clear concentration 1, Other: Thicken up clear concentration 3Thicken Up Clear at concentration 2 |
| Thicken Up Clear concentration 3 | Active comparator | Other: Cereal extract concentration 1, Other: Cereal extract concentration 2, Other: Cereal extract concentration 3, Other: Thicken up clear concentration 1, Other: Thicken up clear concentration 2Thicken Up Clear at concentration 3 |
| Cereal extract concentration 1 | Experimental | Other: Cereal extract concentration 2, Other: Cereal extract concentration 3, Other: Thicken up clear concentration 1, Other: Thicken up clear concentration 2, Other: Thicken up clear concentration 3Cereal extract at concentration 1 |
| Cereal extract concentration 2 | Experimental | Other: Cereal extract concentration 1, Other: Cereal extract concentration 3, Other: Thicken up clear concentration 1, Other: Thicken up clear concentration 2, Other: Thicken up clear concentration 3Cereal extract at concentration 2 |
| Cereal extract concentration 3 | Experimental | Other: Cereal extract concentration 1, Other: Cereal extract concentration 2, Other: Thicken up clear concentration 1, Other: Thicken up clear concentration 2, Other: Thicken up clear concentration 3Cereal extract at concentration 3 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Mild dysphagia as defined by a score between 3 and 5 on the Dysphagia Outcome and Severity Scale
- Patients aged between 18 and 85 years
- Ischemic/hemorrhagic cerebral cause (stroke)
- Able to understand French (oral and written)
- Cognitive capacity enough to understand study procedures
Key exclusion criteria (11 listed)
- Any swallowing trouble not resulting from the current stroke
- History of inhalation pneumopathy, i.e. any pulmonary inflammation linked to the path of a solid or liquid food in the respiratory system
- Any physician diagnosed psychiatric illness
- Patient with a digestive fistula
- Any physician diagnosed food allergy
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 |
|---|---|---|
| Cereal extract concentration 1Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem | Other | Cereal extract concentration 2, Cereal extract concentration 3, Thicken Up Clear concentration 1, Thicken Up Clear concentration 2, Thicken Up Clear concentration 3 |
| Cereal extract concentration 2Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem | Other | Cereal extract concentration 1, Cereal extract concentration 3, Thicken Up Clear concentration 1, Thicken Up Clear concentration 2, Thicken Up Clear concentration 3 |
| Cereal extract concentration 3Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem | Other | Cereal extract concentration 1, Cereal extract concentration 2, Thicken Up Clear concentration 1, Thicken Up Clear concentration 2, Thicken Up Clear concentration 3 |
| Thicken up clear concentration 1Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem | Other | Cereal extract concentration 1, Cereal extract concentration 2, Cereal extract concentration 3, Thicken Up Clear concentration 2, Thicken Up Clear concentration 3 |
| Thicken up clear concentration 2Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem | Other | Cereal extract concentration 1, Cereal extract concentration 2, Cereal extract concentration 3, Thicken Up Clear concentration 1, Thicken Up Clear concentration 3 |
| Thicken up clear concentration 3Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem | Other | Cereal extract concentration 1, Cereal extract concentration 2, Cereal extract concentration 3, Thicken Up Clear concentration 1, Thicken Up Clear concentration 2 |
Primary outcome
Identification of any systematic effect of cohesiveness on the efficacy of swallowing in dysphagic patients according to Rosenbek's Penetration-Aspiration Score (PAS) using videofluoroscopy
Time frame: During the ingestion (videofluoroscopy), maximum during one hour.
The PAS score across each bolus (5 mL and 10 mL)
11 secondary outcomes
Swallowing safety- prevalence of penetration
Time frame: During the ingestion (videofluoroscopy), maximum during one hour.
Swallowing safety- prevalence of aspiration
Time frame: During the ingestion (videofluoroscopy), maximum during one hour.
Swallowing function- Amount/volume of oral and pharyngeal residues
Time frame: During the ingestion (videofluoroscopy), maximum during one hour.
Swallowing function- Prevalence of subjects with oral and pharyngeal residues
Time frame: During the ingestion (videofluoroscopy), maximum during one hour.
Swallowing function- Oral transit time (OTT, time between tongue tip elevation and arrival of the bolus at the ramus of the mandible)
Time frame: During the ingestion (videofluoroscopy), maximum during one hour.
Swallowing function- Swallow response time (SRT, time between arrival of the bolus at the ramus of the mandible and pharyngeal phases of swallowing)
Time frame: During the ingestion (videofluoroscopy), maximum during one hour.
Swallowing function- Pharyngeal transit time (PTT, time between arrival of the bolus at the ramus of the mandible and the tail of the bolus passing through the upper esophageal sphincter)
Time frame: During the ingestion (videofluoroscopy), maximum during one hour.
Swallowing function- Time to upper esophageal sphincter opening (UESO, time between tongue tip elevation and opening of the upper esophageal sphincter)
Time frame: During the ingestion (videofluoroscopy), maximum during one hour.
Swallowing function-Time to laryngeal vestibule opening (LVO, time between tongue tip elevation and pharyngeal phases of swallowing)
Time frame: During the ingestion (videofluoroscopy), maximum during one hour.
Swallowing function- Time to laryngeal vestibule closure (LVC, time between tongue tip elevation and maximal laryngeal closure)
Time frame: During the ingestion (videofluoroscopy), maximum during one hour.
Subjective perception of ease of swallowing and oropharyngeal sensation.
Time frame: Right after ingredient ingestion, maximum during one hour.
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 5 Oct 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cereal extract concentration 1, Cereal extract concentration 2 and Cereal extract concentration 3 in people with Dysphagia and Stroke, run by Société des Produits Nestlé (SPN) at 2 sites in 2 countries.
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 7 inclusion and 11 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 5 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, France. 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?
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?
Identification of any systematic effect of cohesiveness on the efficacy of swallowing in dysphagic patients according to Rosenbek's Penetration-Aspiration Score (PAS) using videofluoroscopy (time frame: During the ingestion (videofluoroscopy), maximum during one hour.). 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 5 Oct 2017.