Probiotic on Prevention of GBS Vaginal Infection During Pregnancy

Sponsor

China Medical University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03688321

Collaborator

(none)

204

Enrollment

Location

Arms

32.2

Actual Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to examine whether oral taking Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 from 28th week of gestation can reduce the GBS colonization rate of vagina and rectum in 35-37 weeks pregnant women as well as during laboring who present with GBS-positive at 28 weeks pregnancy. Through the results of our study, we try to investigate the role of probiotics in preventing the unnecessary tests, admission and antibiotic treatment in newborn with GBS-positive mother who deliver fewer than 4 hours after laboring and the influence of improving cervical diagnostics quality for postpartum Pap testing. Investigators hope the findings may have some effects on GBS sepsis and protocols as well as cervical diagnosis.

Condition or Disease	Intervention/Treatment	Phase
Infection, Bacterial	Dietary Supplement: Probiotic capsule GR-1 and RC-14 Dietary Supplement: Placebo capsule	N/A

Detailed Description

The Centers for Disease Control and Prevention(CDC) guideline in 2010 recommends minimum of 4 hours of intrapartum antibiotics prophylaxis on GBS colonized pregnant women for preventing early-onset GBS infection of neonates. However, GBS-positive mothers who arrive at the labor floor and deliver in fewer than 4 hours is frequent, especially in multiparous mothers. This problem is not easily resolved by antibiotic treatment of the pathogen; thus, such traditional approaches need to be reevaluated. The administration of specific Lactobacilli strains by mouth or intravaginally has been shown to be safe and effective in reducing urogenital infections. Previous results have showed that GR-1 and RC-14 can decrease GBS colonization during the later stage of pregnancy, taking probiotics capsules after GBS test in 35 to 37 weeks pregnant is still have to follow GBS guideline by CDC in 2010 of use antibiotics before delivery. Studies showed the use of antibiotics during pregnancy influenced the GI flora of neonates. Non-antibiotics prophylaxis for preventing newborns' GBS infection and reduce GBS colonization in 35-37 week pregnant are meaningful.

The raised estrogen and growth hormone during pregnancy may increase the activity of HPV molecule and human papilloma virus (HPV) infection. Short-time HPV persistence has been associated with higher risk for cervical intra-epithelial neoplasia and a higher risk of High-Grade Squamous Intraepithelial Lesion(HSIL). Clinical data showed GR-1 and RC-14 can improve the cervical malignancy diagnostics quality for non-pregnant women. The influence of oral probiotics on postpartum cervical diagnosis result is remain unknown.

This study is a prospective double blind randomized clinical trial. Vaginal and rectal GBS test are carried out at 28 weeks of gestation. Subjects with GBS-positive are invited to participate in this study after informed consent. 200 pregnant women 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 18 weeks, and the control group will take 2 capsules of placebos.

Vaginal and rectal GBS culture is repeated in 35-37 week of gestation and intrapartum period. All participators will treat according to GBS guideline by CDC in 2010. Cervical diagnosis will be completed at the 6th week after delivery. Through the results of this study, investigators try to investigate the role of probiotics in preventing the unnecessary tests, admission and antibiotic treatment in newborn with GBS positive mother who deliver fewer than 4 hours after laboring and the influence of improving cervical diagnostics quality for postpartum Pap testing. Investigators hope the findings may have some effects on GBS sepsis and protocols and cervical diagnosis.

Study Design

Study Type:

Interventional

Actual Enrollment :

204 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Study Group: take 2 probiotics capsules before sleep for 12 weeks after being confirmed as GBS positive on 28th gestation Placebo Group: take 2 placebo capsules before sleep for 12 weeks after being confirmed as GBS positive on 28th gestationStudy Group: take 2 probiotics capsules before sleep for 12 weeks after being confirmed as GBS positive on 28th gestation Placebo Group: take 2 placebo capsules before sleep for 12 weeks after being confirmed as GBS positive on 28th gestation

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

Labels with CMUH REC No. plus serial numbers on each bottle been completed by manufacturer and deliver to participants followed by random grouping order.

Primary Purpose:

Prevention

Official Title:

Effects of Oral Probiotic Strains Lactobacillus Rhamnosus GR-1 and Lactobacillus Reuteri RC-14 on Prevention of GBS Vaginal Infection During Pregnancy and Influence of Postpartum Vaginal Health Condition.

Actual Study Start Date :

Oct 24, 2018

Actual Primary Completion Date :

Aug 30, 2020

Actual Study Completion Date :

Jun 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Probiotic capsule GR-1 and RC-14 The intervention for study group is taking 2 capsules containing probiotic strains GR-1 and RC-14 before sleep for 18 weeks after being confirmed as GBS positive on 28th week gestation	Dietary Supplement: Probiotic capsule GR-1 and RC-14 Study Group will take 2 probiotics capsules containing 1 billion colony forming unit(CFU) of Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 each before sleep for 18 weeks starting at 28th week gestation Other Names: U-relax
Placebo Comparator: Placebo capsule The intervention for placebo group is taking 2 capsules not containing probiotic strains GR-1 and RC-14 before sleep for 18 weeks after being confirmed as GBS positive on 28th week gestation	Dietary Supplement: Placebo capsule Placebo Group will take 2 placebo capsules before sleep for 18 weeks starting at 28th week gestation

Arm

Intervention/Treatment

Active Comparator: Probiotic capsule GR-1 and RC-14

The intervention for study group is taking 2 capsules containing probiotic strains GR-1 and RC-14 before sleep for 18 weeks after being confirmed as GBS positive on 28th week gestation

Dietary Supplement: Probiotic capsule GR-1 and RC-14

Study Group will take 2 probiotics capsules containing 1 billion colony forming unit(CFU) of Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 each before sleep for 18 weeks starting at 28th week gestation

Other Names:

U-relax

Placebo Comparator: Placebo capsule

The intervention for placebo group is taking 2 capsules not containing probiotic strains GR-1 and RC-14 before sleep for 18 weeks after being confirmed as GBS positive on 28th week gestation

Dietary Supplement: Placebo capsule

Placebo Group will take 2 placebo capsules before sleep for 18 weeks starting at 28th week gestation

Outcome Measures

Primary Outcome Measures

Change of GBS result from positive to negative will be measured through GBS test for both vagina and rectum in 35-37 weeks pregnant women and during laboring. [18 weeks]
100 participants with GBS positive result recruit on 28th week gestation for each group will recheck GBS colonization through GBS culture test of vagina and rectum in 35-37 weeks gestation as well as during laboring. The percentage of GBS positive turned to negative in the two time points will be measured for study group and placebo group.

Secondary Outcome Measures

The number of normal, inflammation and atypical squamous cells(ASC-US) of the Papanicolaou Stain(PAP smear test) results for study group and placebo group will be measured through cervical PAP Smear Test on the 6th week after laboring. [18 weeks]
100 participants of each group will be examined through cervical PAP smear test to collect the cases of participants with the result of normal, inflammation or ASC-US on the 6th week after laboring for cervical health condition analysis.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

20-45 years old pregnant women
Singleton pregnancy
GBS positive confirmed on 28th week gestation with informed consent form
Agreed to abstain from the use of any systemic or intra-vaginal antibiotic, antifungal agents, or any other intravaginal product(e.g., contraceptive creams, lubricants, and douches) throughout the trial period.

Exclusion Criteria:

Multiple gestations
Impaired immunity, diabetes, or any other kind of significant disease or acute illness that could complicate the evaluation of the results
Received vaginal or systemic antibiotics and antifungal therapy within 2 weeks of the screening visit
Allergy or GI dysfunction history after taking probiotics or yogurt
Constipation