ThickenUp® Gel Express for Patients with Dysphagia

NCT04741581 | Completed

• 1 other identifier: 20.18.CLI
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dysphagia, Esophageal

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Thicken up

OTHER

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

Interventions

ThickenUp® Gel Express DIETARY_SUPPLEMENT

Thickening gel

Thicken up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Hospital de Mataró

Mataró, Spain

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Pere Clavé, MD, PhD

  Hospital de Mataró

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: prospective, open-label

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 5, 2021
• Study Start: May 11, 2021
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: September 19, 2024

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)