Actively Recruiting
Influence of Swallow Gel and Semi-solid Consistency on Medication Dysphagia: A Multicenter Observational Study
Led by Heinrich-Heine University, Duesseldorf · Updated on 2025-11-28
500
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research project investigates how common medication-related swallowing difficulties, known as medication dysphagia, are in patients with diseases affecting swallowing. It aims to understand the frequency of swallowing problems during medication intake and to assess the effects of using semi-solid formulations and a commercial swallowing gel on the swallowing process. The study focuses on patients with neurological and other dysphagia-associated diseases, using flexible endoscopic evaluation of swallowing as the diagnostic standard. Participants will undergo three randomized swallowing trials using placebo medication with different consistencies: methylene-blue-dyed water, a semi-solid vehicle, and the swallowing gel GLOUP . Additionally, standard swallowing tests with food and liquids will be performed. The study includes both patients with neurogenic dysphagia and healthy control subjects for comparison. During the single study visit, swallowing efficiency and safety will be evaluated using a validated FEES-based scoring system. Participants will also rate their swallowing difficulty and related anxiety for each condition on a numerical scale. All assessments occur on the enrollment day, with the goal of providing insight into optimizing medication intake and preventing complications in people with swallowing disorders.
CONDITIONS
Brief Title
GEL & MEDication Dysphagia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with a dysphagia-associated disease such as neurovascular, neurodegenerative, neuroinflammatory, or neuromuscular disorders, or ENT-related diseases when applicable
- Scheduled for a clinically indicated Flexible Endoscopic Evaluation of Swallowing (FEES)
- Able to provide informed consent and cognitively able to follow the study protocol
- Healthy adults without any dysphagia-associated diseases or structural abnormalities of the oropharynx or esophagus
- Able to provide informed consent and cognitively able to follow the study protocol
You will not qualify if you...
- None beyond those specified in the inclusion criteria for patient or healthy control groups
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo a Flexible Endoscopic Evaluation of Swallowing (FEES) to assess medication dysphagia and swallowing function using different consistencies and a swallowing gel.
1 visit (in-person)
Trial Site Locations
Total: 3 locations
1
University Hospital Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany, 40225
Actively Recruiting
2
University Hospital Münster
Münster, North Rhine-Westphalia, Germany, 48149
Actively Recruiting
3
Hospital Osnabrücl
Onsabrück, Germany
Actively Recruiting
Research Team
B
Bendix FEES Labeit, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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