Evaluation of gastrointestinal tolerance of a new thickening powder in patients with dysphagia
| ISRCTN | ISRCTN86521801 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86521801 |
| Protocol serial number | N/A |
| Sponsor | Numico Research BV (Netherlands) |
| Funder | Numico Research BV (Netherlands) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, double blind, active controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Gastrointestinal symptoms (measurements: stool frequency and consistency, GI symptoms and food and fluid intake). |
| Key secondary outcome measure(s) |
1. Patient product acceptability (intake thickening powder) |
| Completion date | 31/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
