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Evaluation of gastrointestinal tolerance of a new thickening powder in patients with dysphagia.


- candidate number1911
- NTR NumberNTR555
- ISRCTNISRCTN86521801
- Date ISRCTN created14-feb-2006
- date ISRCTN requested13-jan-2006
- Date Registered NTR4-jan-2006
- Secondary IDsN/A 
- Public TitleEvaluation of gastrointestinal tolerance of a new thickening powder in patients with dysphagia.
- Scientific TitleEvaluation of gastrointestinal tolerance of a new thickening powder in patients with dysphagia.
- ACRONYMEVATT
- hypothesisH0: 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) studiedDysphagia
- Inclusion criteriaMain 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 criteriaMain 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 receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2005
- planned closingdate31-jul-2006
- Target number of participants50
- InterventionsAfter 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 outcomeGastrointestinal symptoms (measurements: Stool frequency & consistency, GI symptoms and food & fluid intake).
- Secondary outcome1. Patient product acceptibility (intake thickening powder);
2. Carer product evaluation (product evaluation questionnaire).
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES Zandrie Hofman
- CONTACT for SCIENTIFIC QUERIES Zandrie Hofman
- Sponsor/Initiator Danone Research B.V.
- Funding
(Source(s) of Monetary or Material Support)
Danone Research B.V.
- PublicationsAbstract geaccepteerd voor ESPEN 2007.
- Brief summaryStudy to describe the gastrointestinal symptoms on a new thickening powder in amounts likely to be consumed by patients with dysphagia.
- Main changes (audit trail)
- RECORD4-jan-2006 - 2-dec-2008


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