Probiotics for Group B Strep Carrier in Pregnancy

(OPSiP Trial)

Not currently recruiting at 1 trial location

Overseen By Erin Cooke

Age: 18 - 65

Sex: Female

Trial Phase: Phase 3

Sponsor: University of British Columbia

Disqualifiers: Immunosuppression, Diabetes, GBS history, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: Approximately 15 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether specific probiotics taken during pregnancy can reduce Group B Streptococcus (GBS), a bacteria that can affect newborns. Participants will take either probiotics or a placebo starting from the 25th week of pregnancy. If effective, probiotics could reduce the need for antibiotics, benefiting both mothers and babies. This trial suits pregnant women expecting one baby, between 23 and 25 weeks along, who plan to deliver at a participating center. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are planning to use any probiotic supplements during your pregnancy, you may not be eligible to participate.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that taking probiotics during pregnancy is generally safe and well-tolerated. In one study, pregnant women who took probiotics experienced fewer stomach and digestion issues compared to those who took a placebo (a harmless pill with no active ingredients). Another study found that while probiotics didn't change overall health outcomes, they improved the balance of bacteria in the vagina.

These results suggest that probiotics are safe to use during pregnancy, with no serious side effects reported. This is reassuring for those considering participation in a clinical trial for probiotics aimed at reducing Group B Streptococcus (GBS) colonization. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for Group B Strep (GBS) in pregnancy involve antibiotics to eliminate the bacteria. However, probiotics offer a different approach by promoting healthy bacteria that can potentially out-compete the harmful GBS. Researchers are excited about this treatment because it harnesses the body's natural microbiome to manage GBS, potentially reducing the reliance on antibiotics and thus minimizing antibiotic resistance and side effects. This innovative approach could provide a safer and more natural option for expecting mothers.

What evidence suggests that probiotic supplementation might be an effective treatment for Group B Strep in pregnancy?

In this trial, participants will receive either probiotic supplementation or a placebo to evaluate the effects on Group B Streptococcus (GBS) presence during pregnancy. A previous study found that probiotics lowered the presence of GBS in the vagina, with 31.9% of those taking probiotics still testing positive for GBS. However, another study showed that probiotics did not reduce GBS in low-risk women. These mixed results suggest that while probiotics might help some women reduce GBS, they don't work for everyone. Probiotics introduce beneficial bacteria into the body, which might displace the GBS bacteria. More research is needed to confirm these effects in different groups. ^{1 2 3 4 5}

Who Is on the Research Team?

Michelle M Butler, PhD, RM

Principal Investigator

Dublin City University

Patricia Janssen, PhD

Principal Investigator

UBC School of Population and Public Health

Are You a Good Fit for This Trial?

This trial is for pregnant women over 18, with a single baby and less than 25 weeks along. They must be under the care of a maternity provider and planning to deliver at a participating center. Women with significant immunosuppression, prior GBS-affected infants, or certain health conditions like diabetes are excluded.

Inclusion Criteria

Pregnant with a singleton

Gestational age between 23 and 25+0 weeks

Under the care of a regulated maternity care provider (midwife, obstetrician (OB), or family physician)

Exclusion Criteria

GBS bacteriuria diagnosed in present pregnancy (reasoning as per above)

I plan to use probiotic supplements during my pregnancy.

I have Type I or Type II diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive daily oral supplementation of probiotics or placebo from 25 weeks gestation until delivery

Approximately 15 weeks

3 visits (in-person) for swab collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-6 weeks postpartum

Chart review and questionnaires

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Probiotic supplementation

Trial Overview The study tests if taking specific probiotics orally from week 25 of pregnancy reduces Group B Streptococcus colonization compared to a placebo. Participants will take capsules and lozenges daily until they give birth, aiming to lower infant infection risk and antibiotic use.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Probiotic supplementation

Group II: Control Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Dublin City University

Collaborator

Trials

20

Recruited

10,900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9657808/

Supplementation of Probiotics in Pregnant Women Targeting ... Probiotic supplementation reduced vaginal GBS colonization: the GBS positive culture rate was estimated at 31.9% (96/301) in the intervention ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0301211525002453

Probiotics in pregnancy and group B streptococcus ... This study demonstrated that probiotic supplementation in low-risk women did not reduce GBS colonization prior to delivery, and did not influence the mode of ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01479478

Effects of Oral Probiotic Supplementation on Group B Strep ... The investigators wish to determine if oral probiotic supplementation during the second half of pregnancy decreases maternal GBS recto-vaginal colonization.

4. bmjopen.bmj.com bmjopen.bmj.com/content/14/2/e076455.full

Oral Probiotic Supplementation in Pregnancy to Reduce ... The primary outcome will be GBS colonisation status, measured using a vaginal/rectal swab obtained between 35 weeks' gestation and delivery. Secondary outcomes ...

5. evidencebasedbirth.com evidencebasedbirth.com/groupbstrep/

Evidence on Group B Strep in Pregnancy In the year 2015, it was estimated that in-labor antibiotics prevented approximately 29,000 cases of early GBS disease and 3,000 early newborn ...