Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
EVATT
Study 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).
Ethics approval
Received from local medical ethics committee
Study design
Randomised, double blind, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Other
Patient information sheet
Condition
Dysphagia
Intervention
After a 3-day run-in period with current thickening powder patients will receive thickening powder A or B for 14 days.
Measurements of stool frequency and consistency, GI symptoms and food and fluid intake during the study period using food charts, stool charts and GI questionnaires.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Gastrointestinal symptoms (measurements: stool frequency and consistency, GI symptoms and food and fluid intake).
Secondary outcome measures
1. Patient product acceptability (intake thickening powder)
2. Carer product evaluation (product evaluation questionnaire)
Overall trial start date
01/12/2005
Overall trial end date
31/07/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
50
Participant 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
Recruitment start date
01/12/2005
Recruitment end date
31/07/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Numico Research B.V.
Wageningen
6700 CA
Netherlands
Funders
Funder type
Industry
Funder name
Numico Research BV (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary