Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000115336
Ethics application status
Approved
Date submitted
21/02/2008
Date registered
29/02/2008
Date last updated
29/02/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
New approaches to reduce mucosal candidal infections and voice prosthesis failure
Scientific title
Will drinking an anti-Candida milk product reduce damage to and improve time in situ for voice prostheses used by those who have undergone total laryngectomy
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Voice prosthesis failure
Laryngectomy 2859 0
Condition category
Condition code
Respiratory 2991 2991 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participants will drink a milk product which is reconstituted powedered bovine milk pooled from cows immunised with Candida albicans to create anti-candida albicans IgA. As a control the same milk product derived from non-immunised cows milk will be used.
The milk product will be reconsituted with food grade water to a 2gm/L concentration. Twenty mls will be consumed twice daily for the period between valve changes.
At entry to the study participants will undergo a voice prosthesis change and use one or other milk product for three months until the next voice prosthesis change. After the second change they will drink the other milk product for three months and then have a further voice prosthesis change.
This is a crossover trial, the crossover point occurs at the time of a valve change, it is valve damage that is being assessed so washout should not be required
Intervention code [1] 2623 0
Treatment: Other
Comparator / control treatment
The participant is their own control
Control group
Active

Outcomes
Primary outcome [1] 3871 0
Reduced candida colonisation of voice prosthesis.
The primary outcome will be reduced candida colonisation of voice prosthesis. This will be assessed by measuring the yeast and Candida albicans colonisation of removed valves by standard microbiological methods. Selective agar will be used for colony counting of yeasts removed from the explanted valves
Timepoint [1] 3871 0
3 and 6 months
Secondary outcome [1] 6514 0
Improved prosthesis function.
This will be determned by measuring the leakage properties of the removed valves using apparatus developed in our laboratory. An undamaged valve does not leak when placed in this apparatus, whereas damaged valves give a degree of leakage which can be measured to give an estimation of the degree of damage.
Timepoint [1] 6514 0
3 and 6 months

Eligibility
Key inclusion criteria
participant is using a silicone voice prosthesis as part of rehabilitation following total laryngectomy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy or intolerance to milk

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment outside Australia
Country [1] 799 0
New Zealand
State/province [1] 799 0

Funding & Sponsors
Funding source category [1] 3110 0
Hospital
Name [1] 3110 0
Healthcare Otago Charitable Trust
Country [1] 3110 0
New Zealand
Primary sponsor type
Individual
Name
Mr Patrick Dawes
Address
Dept Otorhinolaryngology Head and Neck Surgery (ORL-HNS)
Dunedin Hospital
Private Bag 1921
Dunedin
Country
New Zealand
Secondary sponsor category [1] 2799 0
Individual
Name [1] 2799 0
Dr Ann Holmes
Address [1] 2799 0
Dept Oral Sciences
School of Dentistry
University of Otago
310 Great King Street
Dunedin
Country [1] 2799 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5087 0
Lower South Regional EthicsCommittee
Ethics committee address [1] 5087 0
Ethics committee country [1] 5087 0
New Zealand
Date submitted for ethics approval [1] 5087 0
28/01/2008
Approval date [1] 5087 0
Ethics approval number [1] 5087 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28392 0
Address 28392 0
Country 28392 0
Phone 28392 0
Fax 28392 0
Email 28392 0
Contact person for public queries
Name 11549 0
Patrick Dawes
Address 11549 0
Dept ORL-HNS
Dunedin Hospital
Private Bag 1921
Dunedin
Country 11549 0
New Zealand
Phone 11549 0
+64 3 474 7967
Fax 11549 0
Email 11549 0
[email protected]
Contact person for scientific queries
Name 2477 0
Ann Holmes
Address 2477 0
Dept Oral Science
School of Dentistry
University of Otago
310 Great King Street
Dunedin
Country 2477 0
New Zealand
Phone 2477 0
+64 3 4791200
Fax 2477 0
Email 2477 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.