No registrations found.
ID
Source
Brief title
Health condition
Dysphagia.
Sponsors and support
Bosrandweg 20
P.O. Box 7005
6700 CA Wageningen
The Netherlands
Tel. +31 (0)317-467800
Intervention
Outcome measures
Primary outcome
Gastrointestinal symptoms (measurements: Stool frequency & consistency, GI symptoms and food & fluid intake).
Secondary outcome
1. Patient product acceptibility (intake thickening powder);
2. Carer product evaluation (product evaluation questionnaire).
Background summary
Study to describe the gastrointestinal symptoms on a new thickening powder in amounts likely to be consumed by patients with dysphagia.
Study objective
H0: new thickening powder is equal to current thickening powder (regarding gastrointestinal tolerance).
H1: new thickening powder is unequal to current thickening powder (regarding gastrointestinal tolerance).
Study design
N/A
Intervention
After a 3-days run-in period with current thickening powder patients will receive thickening powder A or B for 14 days.
Measurements of stool frequency & consistency, GI symptoms and food & fluid intake during the study period using food charts, stool charts and GI questionnaires.
PO Box 7005
Zandrie Hofman
Bosrandweg 20
Wageningen 6700 CA
The Netherlands
+31 (0)317 467883
zandrie.hofman@danone.com
PO Box 7005
Zandrie Hofman
Bosrandweg 20
Wageningen 6700 CA
The Netherlands
+31 (0)317 467883
zandrie.hofman@danone.com
Inclusion criteria
Main 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
Main 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 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL513 |
| NTR-old | NTR555 |
| Other | : N/A |
| ISRCTN | ISRCTN86521801 |