None listed
Conditions
Brief summary
Voice prostheses (valves) made of silicone rubber are used to restore speech after laryngectomy for cancer of the larynx. These are frequently colonised by the common oral yeast Candida albicans, which damages and causes failure of teh prosthesis, nescessitating frequent replacement. The overall goal of our research is to develop new ways to prevent C albicans colonisation of voice prosthesis and subsequent valve failure. This proposal plans to evaluate the effect of ingesting bovine milk 9'immune milk') enriched with anti-C albicans IgA (antibody) on reducing voice prosthesis colonisation and damage. We shall perform a cross over study to compare the amount of valve colonisation and damage when an individual drinks either 'immune milk' or a control milk product without the anti-C albicans antibodies. Our hypotheseis is that valve damage will be reduced by treatment with an anti-Candida milk product, previously shown to reduce in vitro colonisation of oral surfaces by C albicans.
Interventions
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 an
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
Sponsors
Mr Patrick Dawes
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
participant is using a silicone voice prosthesis as part of rehabilitation following total laryngectomy
Exclusion criteria
Allergy or intolerance to milk
Outcome results
None listed