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Probiotic on Prevention of GBS Vaginal Infection During Pregnancy (GBS)

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ClinicalTrials.gov Identifier: NCT03688321
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital

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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 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 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 : October 24, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2020

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 Name: 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




Primary Outcome Measures :
  1. 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. [ Time Frame: 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 :
  1. 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. [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688321


Contacts
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Contact: Ming Ho, MD (04)22052121 ext 2063 mi.ho@msa.hinet.net

Locations
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Taiwan
China Medical Univrsity Hoospital Recruiting
Taichung, Taiwan, 40447
Contact: Ming Ho, MD    +886422052121 ext 4798    mi.ho@msa.hinet.net   
Contact: Yi-Yan Chen, MD    +886975681538    d20092@mail.cmuh.org.tw   
Principal Investigator: Ming Ho, MD         
Sponsors and Collaborators
China Medical University Hospital
Investigators
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Principal Investigator: Ming Ho, MD China Medical University Hospital

Publications:
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Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT03688321     History of Changes
Other Study ID Numbers: CMUH107-REC2-104
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Beginning 3 months and ending 5 years following article publication.
Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by China Medical University Hospital:
Probiotics
Group B Streptococcus
Infection
Prevention

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Bacterial Infections