Probiotics for Group B Strep Carrier in Pregnancy (OPSiP Trial)

Phase 3

Waitlist Available

Led By Michelle M Butler, PhD, RM

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Must not have

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)

Type I or Type II diabetes (non-gestational)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up questionnaires administered at intake (22-25 weeks), mid-term (29-33 weeks), term (35-37 weeks) and chart review (4-6 weeks postpartum)

Awards & highlights

Pivotal Trial

Summary

This trial will investigate whether taking probiotics in pregnancy reduces the incidence of Group B Streptococcus colonization. Participants will take probiotics or placebo from 25 weeks gestation until delivery. The primary outcome will be the study-specific vaginal/rectal swab collected after 35 weeks gestation.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Probiotics are generally considered safe but may cause digestive discomfort such as gas or bloating. Since this trial involves pregnant women, it's closely monitored for any adverse effects on both mother and child.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I plan to use probiotic supplements during my pregnancy.

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I have Type I or Type II diabetes.

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I am unable to give my consent.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ questionnaires administered at intake (22-25 weeks), mid-term (29-33 weeks), term (35-37 weeks) and chart review (4-6 weeks postpartum)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~questionnaires administered at intake (22-25 weeks), mid-term (29-33 weeks), term (35-37 weeks) and chart review (4-6 weeks postpartum)

This trial's timeline: 3 weeks for screening, Varies for treatment, and questionnaires administered at intake (22-25 weeks), mid-term (29-33 weeks), term (35-37 weeks) and chart review (4-6 weeks postpartum) for reporting.