What is OPSiP short for?
OPSiP is short for "Oral Probiotic Supplementation in Pregnancy to Reduce Group B Streptococcus Colonization."
What kind of trial is it?
This is a randomized controlled trial. This means that half of the people enrolled will be taking probiotics and the other half will be taking a placebo. The study is blinded, which means no one will know who is taking the probiotic or the placebo, including the participants and the researchers.
How many people will be enrolled?
450 healthy individuals will be enrolled who are receiving care from a regulated maternity care professional (family doctor, obstetrician or midwife).
Where is this study taking place?
In Vancouver, British Columbia. Eligible participants must be registered at either St. Paul's or BC Women's Hospitals in Vancouver, British Columbia. Individuals planning a home birth in Vancouver and are registered at either hospital are also eligible.
Why is this study important?
Group B Streptococcus, commonly known as GBS, is a type of bacteria that up to 30 percent of individuals have in their bodies at the time they give birth. Although this bacteria is ususally harmless, a small percent of babies born to individuals with GBS in their system can become very ill from it. Finding safe and effective ways to reduce the chance of being colonized with GBS will reduce the number of babies that may be at risk of getting an infection from the bacteria.
If I participate, what will I have to do?
- Meet with a study team member in person twice, once at the beginning and once half way through. For your convenience, there are a number of study sites located in the Vancouver area and you can choose the best location for you.
- Do a total of 5 swabs: two of your mouth (we want to know if GBS lives there!) and three vaginal swabs (at intake, mid-point and the routine one after 35 weeks). Just before doing the swabs there will be a few questions to answer (for example, when did you last brush your teeth?). The swabs are easy to do and you can do them yourself or have a clinician do them for you. All of the swabs will be provided to you and doing them does not cause any harm to you or your baby.
- Take the provided supplements (two capsules and one lozenge) daily from 25 weeks of pregnancy until you deliver your baby.
- Complete three short questionnaires (at intake, mid-point and within 2-4 weeks after delivery). The questionnaires can be done online or by hard copy.
Will I get paid to participate in this study?
No. Participating in this study would be on a volunteer basis. However, your supplements and all of the swabs will be provided to you at no cost.
Why should I consider participating?
Clinical trials provide the information needed to find new ways of preventing, detecting, and/or treating diseases. Without study participants, there would be no clinical trials. The OPSiP study will be looking to see if probiotics can prevent GBS colonization and your participation will help us to find this out. If effective, then your help will have paved the way for further research in this area which may then end up being beneficial for future pregnant individuals and their babies.
Also, if you participate and you are randomized to take the probiotic as opposed to the placebo you may benefit from the probiotics (but remember, no one will know which you are taking). However, at the end of the trial you would have the option of being notified of which you took.