Neurological Diseases or ConditionsGELMEDNCT07254663
GEL & MEDication Dysphagia
An observational study of Neurological Diseases or Conditions and Healthy Participants, run by Heinrich-Heine University, Duesseldorf at 3 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neurological Diseases or Conditions, Healthy Participants
- What is being tested?
- medication swallowing
- How many people
- 500 participants
- Where
- 3 sitesGermany
- Study dates
- 15 Sep 2025to 15 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients and relatives of the participating clinics
Who may be able to join
- 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.
Who cannot join
- No additional exclusion criteria beyond those specified in the inclusion criteria.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany3 sites, 3 recruiting
- Recruiting
University Hospital Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225
Bendix FEES Labeit, MD, 0049211 8117887, Bendix.Labeit@med.uni-duesseldorf.de
- Recruiting
University Hospital Münster
Münster, North Rhine-Westphalia, 48149
Sonja Suntrup-Krüger, MD, 0049251 8355555, Sonja.Suntrup-Krueger@ukmuenster.de
Sonja.Suntrup-Krueger@ukmuenster.de
- Recruiting
Hospital Osnabrücl
Onsabrück
Rainer Dziewas, 0049541 4050, Rainer.Dziewas@klinikum-os.de
Rainer.Dziewas@klinikum-os.de
About this study
Official title: Influence of Swallow Gel and Semi-solid Consistency on Medication Dysphagia: A Multicenter Observational Study
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.
Read the detailed description
Dysphagia refers to an impairment of the swallowing process, encompassing the transport of the food bolus from the oral cavity to the gastrointestinal tract. In neurological patients, combined disturbances of the oral and pharyngeal phases frequently occur, known as oropharyngeal dysphagia. This form of dysphagia not only significantly reduces quality of life but may also lead to severe complications.
A particularly relevant aspect of dysphagia is impaired swallowing of medication, referred to as medication dysphagia. This may compromise swallowing efficiency, for example when tablets or capsules remain in the oral cavity or pharynx and dissolve prematurely. Swallowing safety can also be affected, especially in cases of penetration or aspiration during medication intake.
To compensate for these difficulties, patients are often advised to swallow medication together with semi-solid substances instead of liquids. In addition, a commercially available swallowing gel has recently become accessible, designed specifically to facilitate medication intake in patients with dysphagia.
Despite its clinical relevance, medication dysphagia has rarely been investigated systematically with instrumental diagnostics. In particular, the compensatory strategies widely applied in practice have not yet been scientifically evaluated.
Objectives
This research project aims to determine the prevalence of medication dysphagia in patients with dysphagia-associated diseases and to assess the effects of different consistencies on the swallowing process. Specifically, the study will address the following questions:
What is the prevalence of medication dysphagia across different underlying diseases?
Is there an association between medication dysphagia and dysphagia for food and liquids?
How does the addition of a semi-solid vehicle affect the efficiency of medication swallowing?
How does the addition of a semi-solid vehicle affect the safety of medication swallowing?
How does the addition of a semi-solid vehicle influence subjective swallowing difficulties and swallowing-related anxiety during medication intake?
How does the use of a swallowing gel affect the efficiency of medication swallowing?
How does the use of a swallowing gel affect the safety of medication swallowing?
How does the use of a swallowing gel influence subjective swallowing difficulties and swallowing-related anxiety during medication intake?
Study Protocol
This is a prospective, multicenter interventional study. Eligible participants include patients with diseases associated with dysphagia who are scheduled for a clinically indicated Flexible Endoscopic Evaluation of Swallowing (FEES). Healthy control subjects will also be recruited for comparison.
At the University Hospital Düsseldorf, patients with neurovascular, neurodegenerative, neuroinflammatory, or neuromuscular diseases will be included. Medication dysphagia will be assessed using FEES. Three experimental paradigms are planned:
Standard FEES with food and liquid:
In the following order: 10 cc green-colored jelly (semi-solid), 10 cc methylene-blue-dyed liquid, and a piece of white bread (~3 × 3 × 0.5 cm, solid).
Three swallows will be tested for each bolus.
FEES assessment of medication dysphagia:
Three swallow trials will be conducted in randomized order for each of the following conditions:
- Placebo medication with methylene-blue-dyed water.
- Placebo medication with a semi-solid vehicle.
- Placebo medication with the swallowing gel GLOUP®.
Subjective evaluation:
Perceived swallowing difficulty and swallowing-related anxiety will be assessed for each condition using a numerical rating scale (1-10).
Analysis
Medication dysphagia will be evaluated using a previously published and validated FEES-based classification system developed by our research group. This tool enables systematic assessment of swallowing efficiency and safety during medication intake.
- Being tested
- medication swallowing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medication swallowingOther
Three swallow trials will be conducted in randomized order for each of the following conditions:
- Placebo medication with methylene-blue-dyed water.
- Placebo medication with a semi-solid vehicle.
- Placebo medication with the swallowing gel GLOUP®.
| Study group | Role | What they receive |
|---|---|---|
| neurogenic dysphagia group | patients with neurological diseases that may lead to dysphagia Receives: Other: medication swallowing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication dysphagia score according to Labeit et al 2022; DOI: 10.1038/s41531-022-00421-9
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start15 Sep 2025
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological Diseases or ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254663
- Sponsor's protocol ID
- 2024-2989
- Acronym
- GELMED
- Status last verified
- Sep 2025
- First submitted
- 15 Sep 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: demographic data, clinical description of the cohort and swallowing results
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Swallow Gel and Semi-solid Consistency on Medication Dysphagia: A Multicenter Observational Study
- ClinicalTrials.gov ID
- NCT07254663
- Acronym / sponsor ID
- GELMED / 2024-2989
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Dysphagia refers to an impairment of the swallowing process, encompassing the transport of the food bolus from the oral cavity to the gastrointestinal tract. In neurological patients, combined disturbances of the oral and pharyngeal phases frequently occur, known as oropharyngeal dysphagia. This form of dysphagia not only significantly reduces quality of life but may also lead to severe complications.
A particularly relevant aspect of dysphagia is impaired swallowing of medication, referred to as medication dysphagia. This may compromise swallowing efficiency, for example when tablets or capsules remain in the oral cavity or pharynx and dissolve prematurely. Swallowing safety can also be affected, especially in cases of penetration or aspiration during medication intake.
To compensate for these difficulties, patients are often advised to swallow medication together with semi-solid substances instead of liquids. In addition, a commercially available swallowing gel has recently become accessible, designed specifically to facilitate medication intake in patients with dysphagia.
Despite its clinical relevance, medication dysphagia has rarely been investigated systematically with instrumental diagnostics. In particular, the compensatory strategies widely applied in practice have not yet been scientifically evaluated.
Objectives
This research project aims to determine the prevalence of medication dysphagia in patients with dysphagia-associated diseases and to assess the effects of different consistencies on the swallowing process. Specifically, the study will address the following questions:
What is the prevalence of medication dysphagia across different underlying diseases?
Is there an association between medication dysphagia and dysphagia for food and liquids?
How does the addition of a semi-solid vehicle affect the efficiency of medication swallowing?
How does the addition of a semi-solid vehicle affect the safety of medication swallowing?
How does the addition of a semi-solid vehicle influence subjective swallowing difficulties and swallowing-related anxiety during medication intake?
How does the use of a swallowing gel affect the efficiency of medication swallowing?
How does the use of a swallowing gel affect the safety of medication swallowing?
How does the use of a swallowing gel influence subjective swallowing difficulties and swallowing-related anxiety during medication intake?
Study Protocol
This is a prospective, multicenter interventional study. Eligible participants include patients with diseases associated with dysphagia who are scheduled for a clinically indicated Flexible Endoscopic Evaluation of Swallowing (FEES). Healthy control subjects will also be recruited for comparison.
At the University Hospital Düsseldorf, patients with neurovascular, neurodegenerative, neuroinflammatory, or neuromuscular diseases will be included. Medication dysphagia will be assessed using FEES. Three experimental paradigms are planned:
Standard FEES with food and liquid:
In the following order: 10 cc green-colored jelly (semi-solid), 10 cc methylene-blue-dyed liquid, and a piece of white bread (~3 × 3 × 0.5 cm, solid).
Three swallows will be tested for each bolus.
FEES assessment of medication dysphagia:
Three swallow trials will be conducted in randomized order for each of the following conditions:
- Placebo medication with methylene-blue-dyed water.
- Placebo medication with a semi-solid vehicle.
- Placebo medication with the swallowing gel GLOUP®.
Subjective evaluation:
Perceived swallowing difficulty and swallowing-related anxiety will be assessed for each condition using a numerical rating scale (1-10).
Analysis
Medication dysphagia will be evaluated using a previously published and validated FEES-based classification system developed by our research group. This tool enables systematic assessment of swallowing efficiency and safety during medication intake.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neurogenic dysphagia group | – | Other: medication swallowingpatients with neurological diseases that may lead to dysphagia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients and relatives of the participating clinics
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- No additional exclusion criteria beyond those specified in the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medication swallowingThree 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®. | Other | neurogenic dysphagia group |
Primary outcome
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.
Medication dysphagia swallowing score according to FEES (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.
as published here: Labeit et al 2022; doi: 10.1038/s41531-022-00421-9
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: Yes. demographic data, clinical description of the cohort and swallowing results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurological Diseases or Conditions and Healthy Participants, run by Heinrich-Heine University, Duesseldorf at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bendix FEES Labeit, MD (0049211 8117887, Bendix.Labeit@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.