NCT01779193

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P50-P75 for phase_4 pregnancy

Timeline
Completed

Started Jun 2012

Typical duration for phase_4 pregnancy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2015

Enrollment Period

3.1 years

First QC Date

January 28, 2013

Last Update Submit

April 26, 2015

Conditions

Pregnancy

Keywords

group B streptococcuspregnancyprobiotics

Outcome Measures

Primary Outcomes (1)

  • all cases vaginal group B streptococcus colonies

    four years

Study Arms (3)

latic acid bacteria and cranberry

EXPERIMENTAL

oral latic acid bacteria and cranberry capsule (dose of 2 \* 10\^9 cfu per capsule), one pill daily

Dietary Supplement: lactic acid bacteriaDietary Supplement: cranberry

cranberry

ACTIVE COMPARATOR

oral cranberry capsule without lactic acid bacteria, one pill daily

Dietary Supplement: cranberry

placebo

PLACEBO COMPARATOR

placebo without lactic acid bacteria and cranberry, one pill daily

Dietary Supplement: placebo

Interventions

lactic acid bacteriaDIETARY_SUPPLEMENT

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

latic acid bacteria and cranberry
cranberryDIETARY_SUPPLEMENT

oral cranberry capsule, one pill daily

cranberrylatic acid bacteria and cranberry
placeboDIETARY_SUPPLEMENT

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

placebo

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • pregnancy women at 35 weeks of gestation

You may not qualify if:

  • previous other probiotics capsules use
  • previous antibiotics use
  • previous habitual vaginal douche
  • previous medical disease, such as: HIV infection, cancer, history of organ transplantation, long-term steroid use, autoimmune disease, et al

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, College of Medicine, National Cheng Kung University

Tainan, Taiwan

RECRUITING

MeSH Terms

Interventions

Lacteol

Study Officials

  • Meng-Hsing Wu, M.D., Ph.D.

    National Cheng Kung University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Meng-Hsing Wu, M.D., Ph.D.

CONTACT

+88662353535mhwu68@mail.ncku.edu.tw

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
National Cheng Kung University Hospital (NCKUH) Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

January 28, 2013

First Posted

January 30, 2013

Study Start

June 1, 2012

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

April 28, 2015

Record last verified: 2015-04

Locations

TW(1)