GEL & MEDication Dysphagia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHeinrich-Heine University, Duesseldorf
About this trial
This research project examines the prevalence of medication-related dysphagia in patients with dysphagia-associated diseases. Its primary aim is to assess how frequently swallowing difficulties occur during medication intake and to evaluate the impact of different consistencies-such as semi-solid formulations and commercial swallowing gels-on the swallowing process. Flexible endoscopic evaluation of swallowing serves as the diagnostic gold standard to determine whether alternative administration forms can facilitate safer swallowing. The findings are intended to support the optimization of medication intake and the prevention of complications in patients with dysphagia.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Patients and relatives of the participating clinics
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
medication swallowing
Other interventionThree swallow trials will be conducted in randomized order for each of the following conditions: 1. Placebo medication with methylene-blue-dyed water. 2. Placebo medication with a semi-solid vehicle. 3. Placebo medication with the swallowing gel GLOUP®.
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: neurogenic dysphagia group1 intervention
Trial outcomes
Primary outcomes
1
Medication dysphagia score according to Labeit et al 2022; DOI: 10.1038/s41531-022-00421-9
Time frame
on the day of enrollment. This is not a longitudinal study but a one-time examination; all assessments take place on the day of enrollment.2
Medication dysphagia swallowing score according to FEES (Labeit et al 2022; doi: 10.1038/s41531-022-00421-9)
as published here: Labeit et al 2022; doi: 10.1038/s41531-022-00421-9
Time frame
on the day of enrollment. This is not a longitudinal study but a one-time examination; all assessments take place on the day of enrollment.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov