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).
ID
Bron
Verkorte titel
Aandoening
Dysphagia.
Ondersteuning
Bosrandweg 20
P.O. Box 7005
6700 CA Wageningen
The Netherlands
Tel. +31 (0)317-467800
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Gastrointestinal symptoms (measurements: Stool frequency & consistency, GI symptoms and food & fluid intake).
Achtergrond van het onderzoek
Study to describe the gastrointestinal symptoms on a new thickening powder in amounts likely to be consumed by patients with dysphagia.
Doel van het onderzoek
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).
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
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.
Algemeen / deelnemers
PO Box 7005
Zandrie Hofman
Bosrandweg 20
Wageningen 6700 CA
The Netherlands
+31 (0)317 467883
zandrie.hofman@danone.com
Wetenschappers
PO Box 7005
Zandrie Hofman
Bosrandweg 20
Wageningen 6700 CA
The Netherlands
+31 (0)317 467883
zandrie.hofman@danone.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL513 |
| NTR-old | NTR555 |
| Ander register | : N/A |
| ISRCTN | ISRCTN86521801 |