Oral Probiotic Supplementation in Pregnancy to Reduce Group B Streptococcus Colonization (NCT03407157) | Clinical Trial Compass
UnknownPhase 3
Oral Probiotic Supplementation in Pregnancy to Reduce Group B Streptococcus Colonization
Canada168 participantsStarted 2020-01-16
Plain-language summary
This is a double-blind randomized placebo controlled trial that will investigate whether the use of three specific species of probiotics taken orally in pregnancy from 25 weeks gestation will reduce the incidence of Group B Streptococcus (GBS) colonization. Participants will take 2 capsules and 1 lozenge per day of either probiotic or placebo from 25 weeks gestation. The primary outcome will be the study-specific vaginal/rectal swab collected after 35 weeks gestation and before delivery. A reduction in women testing positive for GBS would lead to a decrease risk to infants of GBS infection and a reduction in the use of antibiotics leading to less maternal and neonatal antibiotic exposure.
Who can participate
Age range
18 Years – 55 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Pregnant with a singleton
* Gestational age between 23 and 25+0 weeks
* Over the age of 18
* Registered for delivery, at one of the participating centres
* Under the care of a regulated maternity care provider (midwife, obstetrician (OB), or family physician).
Exclusion Criteria:
* Unable to provide consent
* Fetus has known major anomalies
* Significant immunosuppression
* Type I or Type II diabetes (non-gestational)
* Previous infant with GBS (these women will automatically be advised to be treated with IV antibiotic therapy)
* GBS bacteriuria diagnosed in present pregnancy (reasoning as per above)
* Plans to use oral or vaginal probiotic supplementation/therapy (capsules/tablets/lozenges/drinks) during their pregnancy (outside of natural food sources; yogurt, kimchi, kombucha etc)
* Enrolled in another study that involves the administration of a drug/product
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The primary outcome will be vaginal/rectal GBS colonization status at delivery
Timeframe: Last vaginal/rectal swab taken after 35 weeks gestation and prior to delivery