Dysphagia, EsophagealHYDRA-01NCT04741581
ThickenUp® Gel Express for Patients with Dysphagia
A study testing ThickenUp® Gel Express in people with Dysphagia, Esophageal, run by Société des Produits Nestlé (SPN) at 1 site in Spain.
Trial summary
Evaluation of swallowing function and hydration following consumption of ThickenUp® Gel Express in patients with dysphagia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia, Esophageal
- What is being tested?
- ThickenUp® Gel Express
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 11 May 2021to 31 May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years;
- Diagnosed with oropharyngeal dysphagia and with a documented impaired safety of swallow by V-VST and PAS >1 during VFS;
- History and/or current of swallowing difficulties;
- Willing to adhere to the restrictions specified in the protocol;
- Must be competent to understand the nature of the study and capable of giving written informed consent. In case patients are not capable of providing written informed consent (i.e. affected by dementia) a family/legal representative could provide the consent for the study.
- Willing to report for the scheduled study visits and communicate to study personnel about adverse events and concomitant medication use.
Who cannot join
- Patients suffering from idiosyncratic phenomena or who are allergic to iodinated contrast media;
- Major respiratory disease requiring oxygen or undergoing any type of surgery in the three months prior to the study;
- Current diarrhea, vomiting or abdominal pain;
- Alcohol or drug dependence (based on anamnesis only);
- COVID-19 positive patients (with or without symptoms) at the time of enrolment;
- Patients who, in the judgment of the investigator, are likely to be noncompliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development;
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- Having participated in a clinical study in the last 4 weeks and received compensation beyond a certain approved and predefined limit;
- Having a clinical condition that is contraindicated with the study product;
- Positive urine pregnancy test at screening for women of childbearing potential;
- Allergy towards milk, mustard, egg, or celery.
- Additional inclusion criteria for study part 2 only:
- Patient willing to participate in study part 2;
- Patient/caregiver able to record daily GI symptoms, compliance and fluid intake;
- Patient able to respond to acceptability questionnaire (organoleptic properties, texture, appearance).
- Patient willing to only use study product as the sole thickening agent during the Part 2.
- Additional exclusion criteria for study part 2 only:
- Undergone a major gastrointestinal surgery less than 3 months prior to enrolment in this study;
- Obstruction of the gastrointestinal tract.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect on Swallowing Function As Assessed by a Videofluoroscopy (VFS) One Day Study with Bolus of Various Viscosities, Followed, in a Subset of Patients, by an Acceptability 14 Days Study Combined with an Exploratory Hydration Assessment Study At a Prescribed Viscosity.
Evaluation of swallowing function and hydration following consumption of ThickenUp® Gel Express in patients with dysphagia.
Read the detailed description
ThickenUp® Gel Express for Patients With Dysphagia ("Hydra-01 Study"): Effect on Swallowing Function as Assessed by a Videofluoroscopy (VFS) One Day Study With Bolus of Various Viscosities (Study Part 1) and Followed, in a Subset of Patients, by a United Kingdom Advisory Committee on Borderline Substances (UK ACBS) Acceptability 14 Days Study Combined With an Exploratory Hydration Assessment Study at a Prescribed Viscosity (Study Part 2).
- Conditions
- Dysphagia, Esophageal
- Being tested
- ThickenUp® Gel Express
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThickenUp® Gel ExpressDietary supplement
Thickening gel
| Study group | Role | What they receive |
|---|---|---|
| Thicken up | Other | Assess the effect of ThickenUp® Gel Express at increasing viscosities (slightly thick, nectar, honey, and pudding) on swallowing function compared to water using VFS (N=100), in patients affected by Oropharyngeal dysphagia (OD). Receives: Dietary Supplement: ThickenUp® Gel Express |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penetration-Aspiration Score (PAS)
Part 1 -Bolus penetration into the laryngeal vestibule (PAS Score): the maximum PAS score across the different boluses assessed during videofluoroscopic (VFS) recording.
Measured: 1 day
The United Kingdom Advisory Committee on Borderline Substances (UK ACBS)
Part 2
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start11 May 2021
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysphagia, EsophagealStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective, open-label
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pere Clavé, MD, PhD, Principal investigator, Hospital de Mataró
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741581
- Sponsor's protocol ID
- 20.18.CLI
- Acronym
- HYDRA-01
- Status last verified
- Aug 2022
- First submitted
- 3 Feb 2021
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect on Swallowing Function As Assessed by a Videofluoroscopy (VFS) One Day Study with Bolus of Various Viscosities, Followed, in a Subset of Patients, by an Acceptability 14 Days Study Combined with an Exploratory Hydration Assessment Study At a Prescribed Viscosity.
- ClinicalTrials.gov ID
- NCT04741581
- Acronym / sponsor ID
- HYDRA-01 / 20.18.CLI
- Conditions
- Dysphagia, Esophageal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 11 May 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 5 Feb 2021 (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.
Evaluation of swallowing function and hydration following consumption of ThickenUp® Gel Express in patients with dysphagia.
Detailed description
ThickenUp® Gel Express for Patients With Dysphagia ("Hydra-01 Study"): Effect on Swallowing Function as Assessed by a Videofluoroscopy (VFS) One Day Study With Bolus of Various Viscosities (Study Part 1) and Followed, in a Subset of Patients, by a United Kingdom Advisory Committee on Borderline Substances (UK ACBS) Acceptability 14 Days Study Combined With an Exploratory Hydration Assessment Study at a Prescribed Viscosity (Study Part 2).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective, open-label
| Arm | Type | Receives |
|---|---|---|
| Thicken up | Other | Dietary Supplement: ThickenUp® Gel ExpressAssess the effect of ThickenUp® Gel Express at increasing viscosities (slightly thick, nectar, honey, and pudding) on swallowing function compared to water using VFS (N=100), in patients affected by Oropharyngeal dysphagia (OD). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged ≥ 18 years;
- Diagnosed with oropharyngeal dysphagia and with a documented impaired safety of swallow by V-VST and PAS >1 during VFS;
- History and/or current of swallowing difficulties;
- Willing to adhere to the restrictions specified in the protocol;
- Must be competent to understand the nature of the study and capable of giving written informed consent. In case patients are not capable of providing written informed consent (i.e. affected by dementia) a family/legal representative could provide the consent for the study.
Key exclusion criteria (18 listed)
- Patients suffering from idiosyncratic phenomena or who are allergic to iodinated contrast media;
- Major respiratory disease requiring oxygen or undergoing any type of surgery in the three months prior to the study;
- Current diarrhea, vomiting or abdominal pain;
- Alcohol or drug dependence (based on anamnesis only);
- COVID-19 positive patients (with or without symptoms) at the time of enrolment;
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 |
|---|---|---|
| ThickenUp® Gel ExpressThickening gel | Dietary supplement | Thicken up |
Primary outcome
Penetration-Aspiration Score (PAS)
Time frame: 1 day
Part 1 -Bolus penetration into the laryngeal vestibule (PAS Score): the maximum PAS score across the different boluses assessed during videofluoroscopic (VFS) recording.
The United Kingdom Advisory Committee on Borderline Substances (UK ACBS)
Time frame: 14 days
Part 2
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 19 Sep 2024.
- 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, PhD 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 ThickenUp® Gel Express in people with Dysphagia, Esophageal, run by Société des Produits Nestlé (SPN) 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 6 inclusion and 18 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 19 Sep 2024. 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?
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?
Penetration-Aspiration Score (PAS) (time frame: 1 day). The study lists 2 primary outcomes in all. 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 19 Sep 2024.