Semi-solid foods and swallowing gels to help people who have trouble swallowing pills.
Influence of Swallow Gel and Semi-solid Consistency on Medication Dysphagia: A Multicenter Observational Study
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 |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Heinrich-Heine University, Duesseldorf Academic / other |
| Locations | 3 sites (Düsseldorf, North Rhine-Westphalia and 2 other locations) |
| Trial ID | NCT07254663 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Düsseldorf, North Rhine-Westphalia and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.