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

Primary Purpose

Dysphagia, Esophageal

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

ThickenUp® Gel Express

About this trial

This is an interventional other trial for Dysphagia, Esophageal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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.

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

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;
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.

Sites / Locations

Hospital de Mataró

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Thicken up

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

The United Kingdom Advisory Committee on Borderline Substances (UK ACBS)

Part 2

Secondary Outcome Measures

Full Information

NCT ID

NCT04741581

First Posted

February 3, 2021

Last Updated

November 22, 2022

Sponsor

Société des Produits Nestlé (SPN)

1. Study Identification

Unique Protocol Identification Number

NCT04741581

Brief Title

ThickenUp® Gel Express for Patients With Dysphagia

Acronym

HYDRA-01

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

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

May 11, 2021 (Actual)

Primary Completion Date

May 31, 2022 (Actual)

Study Completion Date

May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Société des Produits Nestlé (SPN)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dysphagia, Esophageal

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

prospective, open-label

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Thicken up

Arm Type

Other

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

ThickenUp® Gel Express

Intervention Description

Thickening gel

Primary Outcome Measure Information:

Title

Penetration-Aspiration Score (PAS)

Description

Part 1 -Bolus penetration into the laryngeal vestibule (PAS Score): the maximum PAS score across the different boluses assessed during videofluoroscopic (VFS) recording.

Time Frame

1 day

Title

The United Kingdom Advisory Committee on Borderline Substances (UK ACBS)

Description

Part 2

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pere Clavé, MD, PhD

Organizational Affiliation

Hospital de Mataró

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital de Mataró

City

Mataró

Country

Spain

12. IPD Sharing Statement

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ThickenUp® Gel Express for Patients With Dysphagia

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