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HYDRA-01: ThickenUp® Gel Express for Patients With Dysphagia

Sponsor
Nestlé (Industry)
Overall Status
Completed
CT.gov ID
NCT04741581
Collaborator
(none)
60
Enrollment
1
Location
1
Arm
12.6
Actual Duration (Months)
4.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluation of swallowing function and hydration following consumption of ThickenUp® Gel Express in patients with dysphagia.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: ThickenUp® Gel Express
 N/A

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

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
prospective, open-labelprospective, open-label
Masking:
None (Open Label)
Primary Purpose:
Other
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.
Actual Study Start Date :
May 11, 2021
Actual Primary Completion Date :
May 31, 2022
Actual Study Completion Date :
May 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Pediatric Appendicitis Score (PAS) [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.

  2. The United Kingdom Advisory Committee on Borderline Substances (UK ACBS) [14 days]

    Part 2

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital de Mataró Mataró Spain

Sponsors and Collaborators

  • Nestlé

Investigators

  • Principal Investigator: Pere Clavé, MD, PhD, Hospital de Mataró

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nestlé
ClinicalTrials.gov Identifier:
NCT04741581
Other Study ID Numbers:
  • 20.18.CLI
First Posted:
Feb 5, 2021
Last Update Posted:
Aug 16, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Deglutition Disorders

Study Results

No Results Posted as of Aug 16, 2022