GEL & MEDication Dysphagia
Influence of Swallow Gel and Semi-solid Consistency on Medication Dysphagia: A Multicenter Observational Study
Heinrich-Heine University, Duesseldorf
500 participants
Sep 15, 2025
OBSERVATIONAL
Conditions
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
Inclusion Criteria5
- Patients:
- Adults with a dysphagia-associated disease (neurovascular, neurodegenerative, neuroinflammatory, or neuromuscular disorders; in other centers also ENT-related diseases), for whom FEES is clinically indicated.
- Capable of providing informed consent and cognitively able to follow the study protocol.
- Healthy Controls Adults without any dysphagia-associated disease (no neurovascular, neurodegenerative, neuroinflammatory, or neuromuscular disorders; no ENT-related diseases with structural abnormalities of the oropharynx or esophagus).
- Capable of providing informed consent and cognitively able to follow the study protocol.
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Interventions
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®.
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT07254663