N/A N=110 Randomized Triple-blind Treatment

Oral Probiotics Reduce Group B Streptococci Colonization in Pregnant Women

Group B Streptococcal Infection

Bottom Line

View on ClinicalTrials.gov: NCT01577108 ↗

Enrolled (actual)

110

Serious AEs

0.0%

Results posted

Mar 2017

Primary outcome: Primary: Number of GBS-Positive Pregnant Women Who Became GBS-Negative at Childbirth — 21; 9 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Probiotic (Dietary_supplement); Placebo (Dietary_supplement)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: China Medical University Hospital
Primary completion: Sep 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of GBS-Positive Pregnant Women Who Became GBS-Negative at Childbirth	21; 9	—

Summary

The purpose of this study is to examine whether daily use of oral gelatin capsules containing dried viable Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 can reduce the GBS colonization rate of vagina and rectum in pregnant women who present with GBS-positive diagnosed by GBS culture at 35-37 weeks gestation. This study is a prospective double blind randomized clinical trial. Vaginal and rectal GBS screening culture are carried out for all pregnant women at 35-37 weeks of gestation in our out-patient department. Subjects with vagina and rectum GBS colonization are invited to participate in our study after informed consent. A total of 200 pregnant women will participate in the study during the 12-months trial period. They are randomly assigned to one of the two groups. The study group is treated with two oral capsules of probiotics once daily (before sleeping) for 14 days, and the control group will take 2 capsules of placebos. Vaginal and rectal GBS culture is repeated for all participators 2 weeks later. All participators will treated according to GBS guideline by CDC in 2002 during laboring.

Eligibility Criteria

Inclusion Criteria

pregnant women with positive GBS screening culture at 35-37 weeks of gestation
singleton gestation
subjects with agreement to abstain from the use of any systemic or intravaginal antibiotic, anti-fungal agents, or any other intravaginal product (i.e., contraceptive creams, gels, foams, sponges, lubricants, douches, etc) throughout the trial period

Exclusion Criteria

multiple gestations
subjects with impaired immunity , diabetes or other significant disease or acute illness that in the investigator's assessment could complicate the evaluation
vaginal or systemic antibiotics or antifungal therapy within 2 weeks of the screening visit.

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Data sourced from ClinicalTrials.gov (NCT01577108). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.