- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03688321
Probiotic on Prevention of GBS Vaginal Infection During Pregnancy (GBS)
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 Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Taichung, Taiwan, 40447
- China Medical Univrsity Hoospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / 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
|
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:
|
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
|
Placebo Group will take 2 placebo capsules before sleep for 18 weeks starting at 28th week gestation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
18 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
18 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ming Ho, MD, China Medical University Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMUH107-REC2-104
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Infection, Bacterial
-
NovartisNovartis VaccinesCompletedBacterial Infection | Streptococcal Infection | Gram-positive Bacterial InfectionBelgium, Canada
-
Kirby InstituteNot yet recruitingInvasive Fungal Infections | Infection, Bacterial | Infection, Fungal | Injection Site Infection | Infection, Soft Tissue | Invasive Bacterial Infection
-
Centre Hospitalier Universitaire de BesanconUnknownAntibiotic Resistant Infection | Resistant Infection | Beta Lactam Resistant Bacterial Infection | Bacterial Resistance
-
Assistance Publique Hopitaux De MarseilleUnknown
-
University of DuhokNot yet recruiting
-
Melinta Therapeutics, Inc.Department of Health and Human ServicesCompletedBacterial InfectionUnited States, Bulgaria
-
University of OxfordCompletedPleural Infection | Pleural Infection BacterialUnited Kingdom
-
Jena University HospitalTerminatedSevere Bacterial InfectionBrazil, Colombia, Germany, Turkey
-
PfizerAllerganTerminatedGram-negative Bacterial InfectionUnited States, Hungary, Slovakia, Taiwan, India, Estonia, Greece, Italy
-
PfizerCompletedGram-negative Bacterial InfectionAustralia
Clinical Trials on Probiotic capsule GR-1 and RC-14
-
China Medical University HospitalCompletedGroup B Streptococcal InfectionTaiwan
-
Lawson Health Research InstituteOntario Neurotrauma FoundationTerminatedUrinary Tract Infections | Spinal Cord InjuryCanada
-
Chang Gung Memorial HospitalCompletedHuman Papillomavirus | Vaginal InfectionTaiwan
-
Lawson Health Research InstituteUniversity of Western Ontario, Canada; St. Joseph's Health Care LondonCompleted
-
Mount Sinai Hospital, CanadaCanadian Institutes of Health Research (CIHR)WithdrawnPremature Birth | Bacterial VaginosisCanada
-
HaEmek Medical Center, IsraelWithdrawnUrinary Tract Infections (UTIs)
-
Baylor College of MedicineLawson Health Research Institute; Chr HansenUnknown
-
The University of Texas Medical Branch, GalvestonCompletedBacterial Vaginosis
-
Western University, CanadaCompletedBacterial Vaginosis | Vulvovaginal CandidiasisRwanda
-
Azienda Ospedaliero, Universitaria PisanaCompleted