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Oral Probiotics Reduce Group B Streptococci Colonization in Pregnant Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01577108
First Posted: April 13, 2012
Last Update Posted: March 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
China Medical University Hospital
  Purpose

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
Group B Streptococcal Infection Dietary Supplement: Probiotic Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
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:
  • Number of GBS-Positive Pregnant Women Who Became GBS-Negative at Childbirth [ Time Frame: 2 weeks after taking probiotic ]
    To exam the GBS colonization in both vagina and rectum when childbirth. 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.


Enrollment: 110
Study Start Date: April 2011
Study Completion Date: July 2013
Primary Completion Date: September 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: Probiotic
oral taking 2 capsules before sleeping per day for 14 days
Other Name: U-relax oral capsule, Lactobacillus GR-1 and RC-14
Placebo Comparator: Non-probiotics, GBS test
Treated with 2 placebo capsules once daily before sleeping for 14 days
Dietary Supplement: Placebo
oral taking 2 capsules before sleeping per day for 14 days
Other Name: Placebo oral capsule

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01577108


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

Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01577108     History of Changes
Other Study ID Numbers: DMR99-IRB-309
First Submitted: July 20, 2011
First Posted: April 13, 2012
Results First Submitted: March 6, 2016
Results First Posted: March 31, 2017
Last Update Posted: March 31, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Infection
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections