Evaluation of gastrointestinal tolerance of a new thickening powder in patients with dysphagia
| ISRCTN | ISRCTN86521801 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86521801 |
| Secondary identifying numbers | N/A |
- Submission date
- 14/02/2006
- Registration date
- 14/02/2006
- Last edited
- 06/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Z. Hofman
Scientific
Scientific
Numico Research B.V.
P.O. Box 7005
Wageningen
6700 CA
Netherlands
Study information
| Study design | Randomised, double blind, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Other |
| Scientific title | |
| Study acronym | EVATT |
| Study objectives | 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(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/12/2005 |
| Completion date | 31/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 50 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/2005 |
| Date of final enrolment | 31/07/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Numico Research B.V.
Wageningen
6700 CA
Netherlands
6700 CA
Netherlands
Sponsor information
Numico Research BV (Netherlands)
Industry
Industry
P.O. Box 7005
Wageningen
6700 CA
Netherlands
"ROR" |
https://ror.org/00aj77a24 |
|---|
Funders
Funder type
Industry
Numico Research BV (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
