Evaluation of gastrointestinal tolerance of a new thickening powder in patients with dysphagia
Completed
- Conditions
- DysphagiaSigns and Symptoms
- Registration Number
- ISRCTN86521801
- Lead Sponsor
- umico Research BV (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
1. Oropharyngeal dysphagia confirmed by the SLT using bed-side swallowing evaluation or videofluoroscopy
2. Neurogenic aetiology or caused by muscle weakness
3. Stable severity (require thickend drinks for at least 3 weeks after inclusion)
4. Written informed consent
Exclusion Criteria
1. Impaired consciousness level
2. Inadequate cognitive skills to comprehend study requirements and to communicate responses to questions
3. Bowel habit unable to be defined using the study specific gastrointestinal (GI) questionnaire
4. Enteral tube feeding corresponding to >50% of total energy intake
5. Use of any foods or fluids thickened with another commercial thickener
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Gastrointestinal symptoms (measurements: stool frequency and consistency, GI symptoms and food and fluid intake).
- Secondary Outcome Measures
Name Time Method 1. Patient product acceptability (intake thickening powder)<br>2. Carer product evaluation (product evaluation questionnaire)