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Oral Probiotics Reduce Group B Streptococci Colonization in Pregnant Women

This study is currently recruiting participants.
Verified April 2012 by China Medical University Hospital
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT01577108
First received: July 20, 2011
Last updated: April 12, 2012
Last verified: April 2012
History of Changes
  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 Phase
Group B Streptococcal Infection
 Dietary Supplement: GR-1, RC-14
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01577108

Contacts
Contact: Ming Ho, MD 886422052121 ext 2063 mi.ho@msa.hinet.net
Contact: Tsan-Hung Chiu, PHD 886422052121 ext 2058 d3868@mail.cmuh.org.tw

Locations
Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan, 403
Contact: Ming Ho, MD     886422052121 ext 2063     mi.ho@msa.hinet.net    
Contact: Tsan-Hung Chiu, PhD     886422052121 ext 2058     d3868@mail.cmuh.org.tw    
Sponsors and Collaborators
China Medical University Hospital
Investigators
Study Director: Ming Ho, MD China Medical University Hospital
  More Information

No publications provided

Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01577108     History of Changes
Other Study ID Numbers: DMR99-IRB-309
Study First Received: July 20, 2011
Last Updated: April 12, 2012
Health Authority: Taiwan: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 18, 2013