Probiotic on Prevention of GBS Vaginal Infection During Pregnancy

NCT ID: NCT03688321

Last Updated: 2021-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-24
• Study Completion Date: 2021-06-30

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.

Conditions

Infection, Bacterial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Probiotic capsule GR-1 and RC-14

Intervention Type: DIETARY_SUPPLEMENT

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

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

Group Type: PLACEBO_COMPARATOR

Placebo capsule

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo capsule

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

U-relax

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ming Ho, MD

Role: PRINCIPAL_INVESTIGATOR

China Medical University Hospital

Locations

China Medical Univrsity Hoospital

Taichung, , Taiwan

Countries

Taiwan

References

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.

Reference Type: BACKGROUND

PMID: 27590374 (View on PubMed)

Other Identifiers

CMUH107-REC2-104

Identifier Type: -

Identifier Source: org_study_id