N/A
Completed N=110
Oral Probiotics Reduce Group B Streptococci Colonization in Pregnant Women
Group B Streptococcal Infection
Source: ClinicalTrials.gov NCT01577108 ↗
Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Number of GBS-Positive Pregnant Women Who Became GBS-Negative at Childbirth — 21; 9 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of GBS-Positive Pregnant Women Who Became GBS-Negative at Childbirth |
21; 9 | — |
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.
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. Informational only — not medical advice.