GEL & MEDication Dysphagia

NCT07254663 | Recruiting

• 1 other identifier: 2024-2989
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Neurological Diseases or Conditions; Healthy Participants

Outcome Measures

Primary Outcomes (2)

• 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)

  as published here: 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.

Study Arms (1)

neurogenic dysphagia group

patients with neurological diseases that may lead to dysphagia

Other: medication swallowing

Interventions

medication swallowing OTHER

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®.

neurogenic dysphagia group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients and relatives of the participating clinics

You may qualify if:

• 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.

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (3)

University Hospital Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

RECRUITING

University Hospital Münster

Münster, North Rhine-Westphalia, 48149, Germany

RECRUITING

Hospital Osnabrücl

Onsabrück, Germany

RECRUITING

Central Study Contacts

Bendix FEES Labeit, MD

CONTACT

0049211 8117887; Bendix.Labeit@med.uni-duesseldorf.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: November 28, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): September 15, 2027
• Last Updated: November 28, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: beginning of recruitment until end of study

Locations

DE (3)