ThickenUp® Gel Express for Patients With Dysphagia (HYDRA-01)

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.

Study Overview

• Status: Completed
• Conditions: Dysphagia, Esophageal
• Intervention / Treatment: Dietary supplement: ThickenUp® Gel Express

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Mataró, Spain
    • Hospital de Mataro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Thicken up; 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).	Dietary supplement: ThickenUp® Gel Express; Thickening gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 day
The United Kingdom Advisory Committee on Borderline Substances (UK ACBS)	Part 2	14 days

Collaborators and Investigators

• Sponsor: Nestlé
• Investigators: Principal Investigator: Pere Clavé, MD, PhD, Hospital de Mataro

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2021
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: February 3, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 22, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: 20.18.CLI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No