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

• ClinicalTrials.gov Identifier: NCT04741581
• Recruitment Status: Recruiting
• First Posted: February 5, 2021
• Last Update Posted: November 29, 2021
• Sponsor: Nestlé
• Information provided by (Responsible Party): Nestlé

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
Dysphagia, Esophageal	Dietary Supplement: ThickenUp® Gel Express	Not Applicable

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 (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: prospective, 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
• Estimated Primary Completion Date: December 31, 2022
• Estimated Study Completion Date: December 31, 2022

Arms and Interventions

Arm	Intervention/treatment
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) [ 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.
2. The United Kingdom Advisory Committee on Borderline Substances (UK ACBS) [ Time Frame: 14 days ]
   Part 2

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Aged ≥ 18 years;
2. Diagnosed with oropharyngeal dysphagia and with a documented impaired safety of swallow by V-VST;
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. 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.

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).

Exclusion Criteria:

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 the anamnesis only);
5. COVID-19 positive patients (with or without symptoms);
6. Patients who, in the judgment of the investigator, are likely to be non-compliant 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 exclusion criteria for study part 2:

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

Contacts and Locations

Contacts

Contact: Elham Pazirandeh Micol; + 41 76 674 1360; elham.pazirandehmicol@nestle.com

Locations

Spain

Hospital de Mataró; Recruiting

Mataró, Spain

Contact: Pere Clavé

Sponsors and Collaborators

Nestlé

Investigators

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

More Information

• Responsible Party: Nestlé
• ClinicalTrials.gov Identifier: NCT04741581
• Other Study ID Numbers: 20.18.CLI
• First Posted: February 5, 2021
• Last Update Posted: November 29, 2021
• Last Verified: November 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases