Clinical trial NCT04741581: ThickenUp® Gel Express for Patients with Dysphagia
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia, Esophageal
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2021-02-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective, open-label
Primary purpose: OTHER

Brief summary: 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).

Eligibility criteria: Key inclusion criteria (for study part 1 and part 2):

1. Aged ≥ 18 years;
2. Diagnosed with oropharyngeal dysphagia and with a documented impaired safety of swallow by V-VST and PAS \>1 during VFS;
3. History and/or current of swallowing difficulties;
4. Willing to adhere to the restrictions specified in the protocol;
5. 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.
6. Willing to report for the scheduled study visits and communicate to study personnel about adverse events and concomitant medication use.

Key exclusion criteria (for study part 1 and part 2):

1. Patients suffering from idiosyncratic phenomena or who are allergic to iodinated contrast media;
2. Major respiratory disease requiring oxygen or undergoing any type of surgery in the three months prior to the study;
3. Current diarrhea, vomiting or abdominal pain;
4. Alcohol or drug dependence (based on anamnesis only);
5. COVID-19 positive patients (with or without symptoms) at the time of enrolment;
6. 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;
7. Having participated in a clinical study in the last 4 weeks and received compensation beyond a certain approved and predefined limit;
8. Having a clinical condition that is contraindicated with the study product;
9. Positive urine pregnancy test at screening for women of childbearing potential;
10. Allergy towards milk, mustard, egg, or celery.

Additional inclusion criteria for study part 2 only:

1. Patient willing to participate in study part 2;
2. Patient/caregiver able to record daily GI symptoms, compliance and fluid intake;
3. Patient able to respond to acceptability questionnaire (organoleptic properties, texture, appearance).
4. Patient willing to only use study product as the sole thickening agent during the Part 2.

Additional exclusion criteria for study part 2 only:

1. Undergone a major gastrointestinal surgery less than 3 months prior to enrolment in this study;
2. Obstruction of the gastrointestinal tract.

Primary outcomes:
measure: Penetration-Aspiration Score (PAS)
timeFrame: 1 day
measure: The United Kingdom Advisory Committee on Borderline Substances (UK ACBS)
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Mataró
country: Spain
facility: Hospital de Mataró
Study officials:
affiliation: Hospital de Mataró
name: Pere Clavé, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: