|- candidate number||1911|
|- NTR Number||NTR555|
|- Date ISRCTN created||14-feb-2006|
|- date ISRCTN requested||13-jan-2006|
|- Date Registered NTR||4-jan-2006|
|- Secondary IDs||N/A |
|- Public Title||Evaluation of gastrointestinal tolerance of a new thickening powder in patients with dysphagia.|
|- Scientific Title||Evaluation of gastrointestinal tolerance of a new thickening powder in patients with dysphagia.|
|- hypothesis||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).
|- Healt Condition(s) or Problem(s) studied||Dysphagia|
|- 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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-dec-2005|
|- planned closingdate||31-jul-2006|
|- Target number of participants||50|
|- Interventions||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.|
|- 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).
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| Zandrie Hofman|
|- CONTACT for SCIENTIFIC QUERIES|| Zandrie Hofman|
|- Sponsor/Initiator ||Danone Research B.V.|
(Source(s) of Monetary or Material Support)
|Danone Research B.V. |
|- Publications||Abstract geaccepteerd voor ESPEN 2007.|
|- Brief summary||Study to describe the gastrointestinal symptoms on a new thickening powder in amounts likely to be consumed by patients with dysphagia.|
|- Main changes (audit trail)|
|- RECORD||4-jan-2006 - 2-dec-2008|