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Oral Probiotics Reduce Group B Streptococci Colonization in Pregnant Women

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2012 by China Medical University Hospital.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
China Medical University Hospital Identifier:
First received: July 20, 2011
Last updated: April 12, 2012
Last verified: April 2012

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.

Condition Intervention Phase
Group B Streptococcal Infection
Dietary Supplement: GR-1, RC-14
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Oral Probiotics Lactobacillus Rhamnosus GR-1 and Lactobacillus Reuteri RC-14 Reduce Group B Streptococci Colonization in Pregnant Women

Resource links provided by NLM:

Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:
  • The purpose of this study is to examine whether oral taking Lactobacillus-containing probiotics can reduce the GBS colonization rate of vagina and rectum in pregnant women who present with GBS-positive. [ Time Frame: 2 weeks after taking probiotic ]

Estimated Enrollment: 200
Study Start Date: April 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probiotics, GBS Test
Treated with 2 oral probiotics once daily before sleeping for 14 days
Dietary Supplement: GR-1, RC-14
oral taking 2 capsules before sleeping per day for 14 days
Other Name: U-relax

  Show Detailed Description


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01577108

China Medical University Hospital
Taichung, Taiwan, 403
Sponsors and Collaborators
China Medical University Hospital
Study Director: Ming Ho, MD China Medical University Hospital
  More Information

Responsible Party: China Medical University Hospital Identifier: NCT01577108     History of Changes
Other Study ID Numbers: DMR99-IRB-309 
Study First Received: July 20, 2011
Last Updated: April 12, 2012

Keywords provided by China Medical University Hospital:
31-32 Weeks of Gestation Completed
Group B Streptococcal Infection
Streptococcus Group B Infection of the Infant

Additional relevant MeSH terms:
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections processed this record on February 20, 2017