Clinical trial NCT03688321: Probiotic on Prevention of GBS Vaginal Infection During Pregnancy
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection, Bacterial
Keywords: Probiotics
Group B Streptococcus
Infection
Prevention
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 204
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 gestation
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 18 weeks
Secondary outcomes:
measure: 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.
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical Univrsity Hoospital
Study officials:
affiliation: China Medical University Hospital
name: Ming Ho, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ho M, Chang YY, Chang WC, Lin HC, Wang MH, Lin WC, Chiu TH. Oral Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 to reduce Group B Streptococcus colonization in pregnant women: A randomized controlled trial. Taiwan J Obstet Gynecol. 2016 Aug;55(4):515-8. doi: 10.1016/j.tjog.2016.06.003.