GEL & MEDication Dysphagia

Condition(s) studied

Investigational drug(s) / intervention(s)

medication swallowing: Three 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®.

Study summary

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

Primary outcome measure(s)

• Medication dysphagia score according to Labeit et al 2022; DOI: 10.1038/s41531-022-00421-9 — 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.
• Medication dysphagia swallowing score according to FEES (Labeit et al 2022; doi: 10.1038/s41531-022-00421-9) — 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.
  as published here: Labeit et al 2022; doi: 10.1038/s41531-022-00421-9

Trial sites (3)

More Heinrich-Heine University, Duesseldorf trials in Germany

Other trials for the same condition