Semi-solid foods and swallowing gels to help people who have trouble swallowing pills.
Official title: Influence of Swallow Gel and Semi-solid Consistency on Medication Dysphagia: A Multicenter Observational Study
Run by Heinrich-Heine University, Duesseldorf · NCT07254663 · Data updated 2026-11-12
This project will test whether taking medications with semi-solid formulations or a commercial swallowing gel helps adults with dysphagia and healthy volunteers swallow pills more safely.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Heinrich-Heine University, Duesseldorf Academic / other |
| Locations | 3 sites (Düsseldorf, North Rhine-Westphalia and 2 other locations) |
| Status | Recruiting |
| Started | September 15, 2025 |
| Main results expected | September 15, 2027 |
| Study ends | September 15, 2027 |
| Registry record updated | November 28, 2025 |
| Trial ID | NCT07254663 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with neurovascular, neurodegenerative, neuroinflammatory, neuromuscular, or ENT-related conditions who are clinically referred for FEES and can give informed consent, plus healthy adult volunteers without these conditions for controls.
✕Probably not a fit
People who cannot tolerate or undergo FEES, those with structural esophageal obstruction, or those with severe cognitive impairment preventing protocol participation are unlikely to benefit directly from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study uses flexible endoscopic evaluation of swallowing (FEES) as the diagnostic gold standard to document how often medication-related swallowing problems occur in people with dysphagia-associated diseases and in healthy controls. Participants will attempt medication intake with different consistencies, including semi-solid carriers and a commercially available swallowing gel, while clinicians record safety and bolus transport findings. The primary goals are to measure the prevalence of medication dysphagia and to compare whether alternative consistencies reduce penetration, aspiration, or residue during swallowing. Results aim to inform practical recommendations for safer medication administration in affected patients.
Why it matters
Potential benefit: If successful, the findings could identify simple, safer ways to take pills that reduce choking, aspiration, and medication-related complications for people with dysphagia.
How similar studies have gone: Instrumental, systematic research on medication swallowing aids is limited; small reports and routine clinical practice suggest semi-solid carriers and gels may help, but large objective datasets are lacking.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Exclusion Criteria: No additional exclusion criteria beyond those specified in the inclusion criteria.
Where it's running
-
University Hospital Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany Recruiting -
University Hospital Münster
Münster, North Rhine-Westphalia, Germany Recruiting -
Hospital Osnabrücl
Onsabrück, Germany Recruiting
Study contacts
- Study coordinator: Bendix FEES Labeit, MD
- Email: Bendix.Labeit@med.uni-duesseldorf.de
- Phone: 0049211 8117887
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.