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Probiotics Capsule as Supplemental Therapy for Group B Streptococci Infection and Vaginitis During Pregnancy

NCT01779193 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2015-04-28

No results posted yet for this study

Summary

B streptococcal infection and the major cause of death before and after the baby is born. B streptococcus infection the way of the newborn, usually infection from the mother in childbirth, if the pregnant women during pregnancy early diagnosis B streptococcus infection, it can be effective in preventing the risk of neonatal infection. Department of Health in China has been since April 15, 2012, the Scholarship holder at all pregnant women in the 35-37 weeks of pregnancy comprehensive B streptococcus screening. Infection B Streptococcus pregnant women in the labor process, the use of prophylactic antibiotics can be effective in reducing neonatal B streptococcus infection, but the possibility of the fetus being infected for the condition of premature birth or early rupture of membranes are still unable to fully hedge. In this study, the 35 to 37 weeks gestation examination confirmed infected B Streptococcus pregnant women, oral lactobacillus capsules B streptococcus infection treatment efficacy and safety assessment of clinical research. To assess whether oral administration of lactic acid bacteria will affect vaginitis incidence.

Conditions

  • Pregnancy

Interventions

DIETARY_SUPPLEMENT

lactic acid bacteria

oral lactobacillus capsule (dose of 2 \* 10\^9 cfu per capsule), one pill daily

DIETARY_SUPPLEMENT

cranberry

oral cranberry capsule, one pill daily

DIETARY_SUPPLEMENT

placebo

placebo capsule without lactic acid bacteria and cranberry, one pill daily

Sponsors & Collaborators

  • National Cheng-Kung University Hospital

    collaborator OTHER

  • Meng-Hsing Wu

    lead OTHER

Principal Investigators

  • Meng-Hsing Wu, M.D., Ph.D. · National Cheng Kung University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01779193 on ClinicalTrials.gov