PRINCESS: Information for Care Home Residents
What does taking part in the study involve?
Taking part in the study involves 5 key steps:
1. If, after finding out more about the study, you decide that you would like to go ahead and take part, you will be asked to sign a consent form.
2. A computer will then randomly assign you to one of two groups:
3. You will be asked to take 1 capsule a day for 12 months (care home staff will give this out with your daily medications).
The capsule can be swallowed whole or it can be opened and the powder inside can be sprinkled into a cool drink or onto cool food.
4. During the 12 months, a research nurse will visit you on 3 occasions to ask some questions about your general health and take some measurements (such as height, weight and arm circumference).
The Research Nurse will also regularly look at your care home notes and chat with care home staff to find out if you have been unwell and if you have been taking antibiotics.
5. An optional part of the study involves agreeing to give a small blood sample, a stool (faeces) sample and a saliva sample. However, you can still take part in the study if you choose not to provide any or all of these samples.
More detailed information is provided in a PRINCESS participant information booklet. If your care home has agreed to host the study, you can ask staff for a copy.
Who is suitable to take part in the study?
Most people who are aged 65 or older and currently living in a care home setting can take part in the PRINCESS study.
Note: it is only possible to take part in the PRINCESS study if your care home has agreed, or is willing,to host the study (a list of care homes that are currently taking part can be found here).
What are the benefits of taking part?
There may, or may not be, a direct benefit to you personally if you decide to take part in the study. However, the study will help us to find out if probiotics could be a useful way of preventing infections in older people - this could benefit all people living in care homes in future years.
What are the risks of taking part?
Probiotics are classed as a food supplement and are considered very safe to take. Side effects are very rare. The most common side effect is mild bloating of the tummy or abdomen.
How can I find out more about the study?
If your care home has agreed to host the PRINCESS study, you can find out more from your care home staff (a list of care homes that are currently taking part can be found here).
One of our Research Nurses can visit to chat about the study with you and your family/friends if you would like.
There is no obligation to take part; this is completely up to you. Your care and treatment will not be affected whatever you decide. If you decide to join the study, you are free to change your mind or withdraw at any time.