The Efficacy of Probiotics to Reduce Antepartum Group B Streptococcus Colonization. (NCT03696953) | Clinical Trial Compass
UnknownPhase 2
The Efficacy of Probiotics to Reduce Antepartum Group B Streptococcus Colonization.
United States109 participantsStarted 2019-02-01
Plain-language summary
This study is a randomized double blind, placebo controlled trial to determine the efficacy of an oral probiotic in reducing antenatal Group B Streptococcus colonization. The goal of this study is to demonstrate that women in the probiotics group will experience; (1) reduced GBS prenatal colonization at 36± 2 weeks gestation and lower levels of GBS colonization, (2) less need for intrapartum antibiotic prophylaxis and (3) fewer prenatal gastrointestinal symptoms compared to women in the placebo group.
Intrapartum measures were added and IRB approved in Feb 2020 as a pilot and feasibility substudy. The goals of this study are as follows: (1) Explore the effect of antepartum exposure to Florajen3 on maternal and neonatal residual GBS and the maternal microbiome. We anticipate that (1)At the time of labor, more women in the probiotics group will test negative for GBS on vaginal to rectal swabs compared to those in the placebo group and (2) Fewer neonates born to women in the probiotic group will have GBS on nasal-oral pharynx cultures within several hours of birth compared to those born to neonates in the control group.
Who can participate
Age range
18 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:
* Healthy adult (≥ 18 years of age) pregnant women who are 28±2 weeks gestation at enrollment \[calculated from the first day of Last Normal Menstrual Period (LNMP) and/or ultrasound (US)\]
* With: No obstetric complication\* (e.g., pre-eclampsia, gestational diabetes, multiple gestation)
* No fetal complication (e.g., birth defect, intrauterine growth restriction)
* No medical complication (e.g., hypertension, diabetes mellitus)
* Who do not currently ingest an over the counter probiotic supplement (not including yogurt)
* Who can both speak and read English
* Who regularly attend prenatal care (defined as not \> 1 prior missed appointment during this pregnancy)
* No Hypersensitivity reaction to β-lactam antibiotics
Exclusion Criteria:
* Those less than 18 years of age
* Non-pregnant women
* Later in pregnancy than 30 weeks gestation at enrollment \[per LNMP and/or US\]
* Those with an obstetric, fetal or medical complication of pregnancy
* Pregnant women who have a history of GBS bacteriuria during the current pregnancy or have previously given birth to a GBS affected child
* Women who are currently ingesting an over the counter probiotic supplement (except for yogurt)
* Women who are planning an elective repeat cesarean birth
* Women who do not speak and read English
* Women with a history of missing more than one scheduled prenatal visit during this pregnancy
* Hypersensitivity reaction to β-lactam antibiotics
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.