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Probiotic

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

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

OPSiP 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.Check my eligibility

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.See study design

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.

OPSiP Trial 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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The will be vaginal/rectal GBS colonization status at delivery

Secondary outcome measures

Maternal antibiotic exposure

Maternal bacterial vaginosis infections

Maternal urinary tract infections

+1 more

Other outcome measures

(Direct) infant exposure to antibiotics

Admission of infant to Neonatal Intensive Care Unit (NICU)

Adverse events

+10 more

OPSiP Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: InterventionExperimental Treatment1 Intervention

Probiotic supplementation

Group II: ControlPlacebo Group1 Intervention

Placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Probiotic supplementation

2007

N/A

~200

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor

1,415 Previous Clinical Trials

2,466,848 Total Patients Enrolled

Dublin City UniversityOTHER

19 Previous Clinical Trials

11,476 Total Patients Enrolled

Michelle M Butler, PhD, RMPrincipal InvestigatorDublin City University

Media Library

Probiotic supplementation (Probiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03407157 — Phase 3

Group B Strep Carrier Research Study Groups: Intervention, Control

Group B Strep Carrier Clinical Trial 2023: Probiotic supplementation Highlights & Side Effects. Trial Name: NCT03407157 — Phase 3

Probiotic supplementation (Probiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03407157 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would this research be available to adults over the age of 35?

"The adults aged 18-55 years old fall within the age range that is able to participate in this clinical trial."

Answered by AI

Are there any specific conditions that make a person ineligible for this research project?

"Up to 450 expectant mothers who are under the care of an obstetrician, midwife, or family physician and are pregnant with a single child can participate in this clinical trial. The study requires that participants be between 18 and 25 weeks gestation, be registered for delivery at one of the participating centres, and meet the following age criteria: Over the age of 18."

Answered by AI

Can people with the required medical conditions participate in this trial at this time?

"This study is still recruiting patients, as seen on clinicaltrials.gov. The listing was first created on January 16th, 2020 and was last updated the following day."

Answered by AI

How many willing participants are being accepted into this clinical trial?

"That is accurate. The clinicaltrial.gov website has the latest information on this study, which is looking for 450 people to participate between 2 sites. The study was posted on 1/16/2020 and was updated on 1/17/2020."

Answered by AI

Does the FDA recognize Probiotic supplementation as a legitimate form of medication?

"While Phase 3 trials are not as conclusive as Phase 4 trials, there is some evidence that probiotic supplementation is effective and safe. Our team at Power rates the safety of this supplement as a 3."

Answered by AI

Recent research and studies

PediatricsJournal

Association of Intrapartum Antibiotic Exposure and Late-onset Serious Bacterial Infections in Infants

Glasgow, Tiffany S., Paul C. Young, Jordan Wallin, Carolyn Kwok, Greg Stoddard, Sean Firth, Matthew Samore, and Carrie L. Byington. 2005. “Association of Intrapartum Antibiotic Exposure and Late-onset Serious Bacterial Infections in Infants”. Pediatrics. American Academy of Pediatrics (AAP). doi:10.1542/peds.2004-2421.

escherichia ColiJournal

Changing Patterns in Neonatal <i>escherichia Coli</i> Sepsis and Ampicillin Resistance in the Era of Intrapartum Antibiotic Prophylaxis

Bizzarro, Matthew J., Louise-Marie Dembry, Robert S. Baltimore, and Patrick G. Gallagher. 2008. “Changing Patterns in Neonatal escherichia Coli Sepsis and Ampicillin Resistance in the Era of Intrapartum Antibiotic Prophylaxis”. Pediatrics. American Academy of Pediatrics (AAP). doi:10.1542/peds.2007-2171.

Nature Reviews EndocrinologyJournal

Antibiotics in Early Life and Obesity

Cox, Laura M., and Martin J. Blaser. 2014. “Antibiotics in Early Life and Obesity”. Nature Reviews Endocrinology. Springer Science and Business Media LLC. doi:10.1038/nrendo.2014.210.

Menopause InternationalJournal