Oral Probiotics Reduce Group B Streptococci Colonization in Pregnant Women

NCT01577108 | Completed Results DMC

• 1 other identifier: DMR99-IRB-309
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Group B Streptococcal Infection

Keywords

31-32 Weeks of Gestation Completed; Group B Streptococcal Infection; Streptococcus Group B Infection of the Infant

Outcome Measures

Primary Outcomes (1)

• Number of GBS-Positive Pregnant Women Who Became GBS-Negative at Childbirth

  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.

  2 weeks after taking probiotic

Study Arms (2)

Probiotics, GBS Test

EXPERIMENTAL

Treated with 2 oral probiotics once daily before sleeping for 14 days

Dietary Supplement: Probiotic

Non-probiotics, GBS test

PLACEBO COMPARATOR

Treated with 2 placebo capsules once daily before sleeping for 14 days

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

oral taking 2 capsules before sleeping per day for 14 days

Also known as: U-relax oral capsule, Lactobacillus GR-1 and RC-14

Probiotics, GBS Test

Placebo DIETARY_SUPPLEMENT

oral taking 2 capsules before sleeping per day for 14 days

Also known as: Placebo oral capsule

Non-probiotics, GBS test

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan, 403, Taiwan

Location

MeSH Terms

Conditions

Streptococcal Infections

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Ming Ho, MD
• Organization: China Medical University Hospital

mi.ho@msa.hinet.net

886422052121

Study Officials

• Ming Ho, MD

  China Medical University Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2011
• First Posted: April 13, 2012
• Study Start: April 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: July 1, 2013
• Last Updated: March 31, 2017
• Results First Posted: March 31, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)