ThickenUp® Gel Express for Patients with Dysphagia

NCT ID: NCT04741581

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-11
• Study Completion Date: 2022-05-31

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).

Conditions

Dysphagia, Esophageal

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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).

Group Type: OTHER

ThickenUp® Gel Express

Intervention Type: DIETARY_SUPPLEMENT

Thickening gel

Interventions

ThickenUp® Gel Express

Thickening gel

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

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.

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.

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 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.

1. Undergone a major gastrointestinal surgery less than 3 months prior to enrolment in this study;

2. Obstruction of the gastrointestinal tract.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pere Clavé, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Mataró

Locations

Hospital de Mataró

Mataró, , Spain

Countries

Spain

Other Identifiers

20.18.CLI

Identifier Type: -

Identifier Source: org_study_id