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PregnancyPhase 4NCT01779193

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

A Phase 4 study testing lactic acid bacteria and cranberry in people with Pregnancy, run by Meng-Hsing Wu at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy
What is being tested?
lactic acid bacteria and cranberry
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
1 siteTaiwan
Study dates
Jun 2012to Jul 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • pregnancy women at 35 weeks of gestation

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

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

+88662353535 ext. 5222

mhwu68@mail.ncku.edu.tw

Taiwan1 site, 1 recruiting
  • Department of Obstetrics and Gynecology, College of Medicine, National Cheng Kung University

    Tainan

    Meng-Hsing Wu, M.D., Ph.D., +88662353535 ext. 5222, mhwu68@mail.ncku.edu.tw

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

    Recruiting

Other trials in Taiwan

About this study

Official title: A Double-blind,Randomized,Parallel,Placebo-controlled Study of Probiotics Capsule as Supplemental Therapy for Group B Streptococci Infection and Vaginitis During Pregnancy

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.

Read the detailed description

Deeply influenced of bacterial vaginosis infection during pregnancy for pregnant women and fetus during childbirth, in which Group B Streptococcus agalactiae(GBS) is generally about 30% of pregnant women will be infected, about 1% vertical and infect the fetus, babies are not infected about 50% of the mortality rate in the treatment status, is considered an important reason for infection and death before and after the baby is born. Vertically in the natural childbirth process and infect the fetus, the delay in treatment on the fetus often lead to serious complications, including sepsis, pneumonia and meningitis, a serious will to cause death and permanent neurological sequelae, if given to confirm the diagnosis antibiotic treatment of pregnant women, the probability of infection of the newborn B streptococcus can be reduced by 75%. U.S. Centers for Disease Control recommends that pregnant women 35 to 37 weeks gestation or less than 37 weeks preterm contractions or rupture of membranes. B streptococcus check preterm doubts should pregnant women in the labor process and the use of preventive antibiotics can be effective in reducing neonatal B streptococcus infection, but the condition of premature birth or early rupture of membranes can not fully prevent the possibility of the fetus being infected is still in pre-production will not make any disposal, can cause infection of B The streptococci pregnant women worry, and under great pressure. This study for 35 to 37 weeks gestation to check to confirm infection of B Streptococcus pregnant women, pregnant women infected with the clinical studies of treatment efficacy and safety assessment of B streptococcus before delivery to the oral administration of lactic acid bacteria. The trial is expected during the execution in June 2012 to July 2015, subjects the number is expected to included at least 120 pregnant women choose not to subjects according to the conventional injection of prophylactic antibiotics in the labor process, choose to take oral lactobacillus oral lactobacillus of pregnant women in accordance with the 1:1 double-blind randomized to three groups, one of the following: test group A: oral lactobacillus capsules (dose of 2 x 109 cfu / capsule), experimental group B: oral without functional lactobacillus capsules and the control group: oral administration does not contain the active ingredient (lactic acid bacteria and cranberry) capsules before oral administration of lactic acid bacteria and the delivery process, collecting samples of vaginal anal secretions, whether positive addition to the screening B streptococcus, and the other selective medium coated plate culture for vaginal odor, itching number of the pathogen and B Streptococcus quantitative analysis and assessment questionnaire.

Conditions
Pregnancy
Being tested
lactic acid bacteria, cranberry, placebo
Keywords
group B streptococcus, pregnancy, probiotics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lactic acid bacteriaDietary supplement

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

  • cranberryDietary supplement

    oral cranberry capsule, one pill daily

  • placeboDietary supplement

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

Study groups in NCT01779193
Study groupRoleWhat they receive
latic acid bacteria and cranberryExperimentaloral latic acid bacteria and cranberry capsule (dose of 2 * 10^9 cfu per capsule), one pill daily
Receives: Dietary Supplement: lactic acid bacteria; Dietary Supplement: cranberry
cranberryActive comparatororal cranberry capsule without lactic acid bacteria, one pill daily
Receives: Dietary Supplement: cranberry
placeboPlacebo comparatorplacebo without lactic acid bacteria and cranberry, one pill daily
Receives: Dietary Supplement: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. all cases vaginal group B streptococcus colonies

    Measured: four years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2013 (estimated)
  2. Study startJun 2012
  3. Primary completionJul 2015 (estimated)
  4. Study completionJul 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01779193
Sponsor's protocol ID
A-BR-101-065
Status last verified
Apr 2015
First submitted
28 Jan 2013
Last updated
28 Apr 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing lactic acid bacteria and cranberry in people with Pregnancy, run by Meng-Hsing Wu at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Meng-Hsing Wu, M.D., Ph.D. (+88662353535 ext. 5222, mhwu68@mail.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

all cases vaginal group B streptococcus colonies (time frame: four years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2015.

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