Condition category
Signs and Symptoms
Date applied
14/02/2006
Date assigned
14/02/2006
Last edited
06/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Z. Hofman

ORCID ID

Contact details

Numico Research B.V.
P.O. Box 7005
Wageningen
6700 CA
Netherlands

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

Sponsor information

Organisation

Numico Research BV (Netherlands)

Sponsor details

P.O. Box 7005
Wageningen
6700 CA
Netherlands

Sponsor type

Industry

Website

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

Publication citations

Additional files

Editorial Notes