Bacterial VaginosisPhase 1BVNCT01421615
Effect of Different Courses of Lactobacilli Treatment on Bacterial Vaginosis and Pregnancy Outcomes
A Phase 1 study testing Vaginal capsules of lactobacilli in people with Bacterial Vaginosis, run by The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine at 1 site in China.
Trial summary
The purpose of this study is to examine the effect of lactobacillus preparation on Bacterial vaginosis (BV) in low-risk pregnant women and to evaluate the value of double courses for the patients with durative positive result. 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
- Bacterial Vaginosis
- What is being tested?
- Vaginal capsules of lactobacilli
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to May 2012
- Phase
- Phase 1
- 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
- pregnant women at 16-18 gestational weeks with no history of premature labor or premature rupture of fetal membranes.
Who cannot join
- who have menstrual disorder or forget the last menstrual period, and have no type-B ultrasonic result, so the gestational week is not clear.
- Who have monilial vaginitis, trichomonas vaginitis, or sexual transmitted diseases.
- who have severe medicochirurgic diseases.
- multiple pregnancy.
- anomalies of genital tract
- fetal anomaly
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Maternal and child care hospital in Panyu District
Guangzhou, Guangdong, 511400
Yanfang LEE, 13928777126, 13928777126@139.com
Yanfang LEE
About this study
Official title: Effect of Different Courses of Lactobacilli Treatment on Bacterial Vaginosis and Related Pregnancy Outcomes
The purpose of this study is to examine the effect of lactobacillus preparation on Bacterial vaginosis (BV) in low-risk pregnant women and to evaluate the value of double courses for the patients with durative positive result. It is assumed that the living preparation of lactobacillus was beneficial for treatment of BV during pregnancy. The two-courses treatment can increase the response rate and improve pregnancy outcomes in the durative BV positive patients comparing with one-course one.
Read the detailed description
Research method: This was a single-blind randomized controlled trial.
Diagnostic standard: The study population is the women who have positive outcome of screened test for BV by sialidase method.
Allocation and follow up: Patients who were screened for BV by sialidase method and randomly allocated into control group、one-course group and two-course group. The patients in control group who were BV positive would receive lotion washout and be repeatedly evaluated BV status per two weeks and be followed up to the 4th～7th days of postpartum. The patients in one-course group and in two-course group who were BV positive would receive the first course treatment of vaginal lactobacillus capsule and be repeatedly evaluated BV status after treatment. The patients in two-course group will receive the second course treatment of Lactobacilli preparation if their BV test result were still positive after one-course treatment, but those in one-course group would NOT receive any treatment even though they would have the durative BV positive result after one-course of Lactobacilli. The patients in the two interventional groups would be repeatedly evaluated BV status at 28th gestational weeks and be followed up to the 4th-7th days of postpartum. All the inspection results of vaginal secretions and pregnancy outcome were recorded.
Outcome measures:
- The prevalence of BV,the response rates of lactobacillus preparation,the recurrence rate.
- The adverse pregnancy outcomes of mother.
- The adverse pregnancy outcomes of perinatal fetus.
- Conditions
- Bacterial Vaginosis
- Being tested
- Vaginal capsules of lactobacilli
- Keywords
- Bacterial vaginosis, Probiotics, Lactobacilli, Pregnancy outcome, Randomized controlled trial
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal capsules of lactobacilliDrug
Also called Brand names: Dingjunsheng, Commodity code name: A246912309879, Approved by the state: S20030005
The patients in one-course group who were BV positive would receive the first course treatment of vaginal lactobacillus capsule and be repeatedly evaluated BV status after treatment. If their BV test result were still positive after one-course treatment, they would NOT receive any treatment but would be followed up to the 4th-7th days of postpartum.
Vaginal capsules of lactobacilliDrug
Also called Brand names: Dingjunsheng, Commodity code name: A246912309879, Approved by the state: S20030005
The patients in two-course group who were BV positive would receive the first course treatment of vaginal lactobacillus capsule and be repeatedly evaluated BV status after treatment. If their BV test result were still positive after one-course treatment, they will receive the second course treatment of Lactobacilli preparation.
| Study group | Role | What they receive |
|---|---|---|
| lotion | Placebo comparator | lotion:the patients in control group receive washing medicine and are followed up to the 4rd～7th days of postpartum. Receives: Drug: Vaginal capsules of lactobacilli |
| lactobacilli capsule | Experimental | Not described Receives: Drug: Vaginal capsules of lactobacilli |
| lactobacilli capsules | Experimental | Not described Receives: Drug: Vaginal capsules of lactobacilli |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants who transformed to negative status of bacterial vaginosis
The patients who were BV positive would receive treatment and be repeatedly evaluated BV status on the time of post-treatment 1 week, 28th gestational weeks, and before birth, respectively.The number of Participants who transformed to negative status of bacterial vaginosis will be recorded. The rates of bacterial vaginosis transformed to negative status will be calculated.
Measured: 6 months
Secondary outcomes (3)
pregnancy outcome of mother
- the delivery weeks
- the delivery mode
- the presence of premature rupture of fetal membra
- the presence of premature labor
- the volume of postpartum haemorrhage
- the presence of pregnancy complications
- the highest temperature during the first three days of postpartum
Measured: 6 months (from 16~18 gestational weeks to the 4th-7th days of postpartum)
pregnancy outcome of perinatal fetus
- the neonatal birth weight
- the presence of fetal distress
- the neonatal 1 min Apgar score
- the numerically highest value of neonatal transcutaneous bilirubinometry
Measured: 6 months (from 16~18 gestational weeks to the 4th-7th days of postpartum)
Safety and tolerability
- liver function test
- renal function test
Measured: 6 months (from 16~18 gestational weeks to the 4th-7th days of postpartum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2011 (estimated)
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, China
- Responsible party
- Principal investigator, Li Yanfang, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
- Investigators
- Yanfang Lee, Master, Principal investigator, The First Affiliated Hospital of Guangzhou University of TCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01421615
- Sponsor's protocol ID
- GZ board of health
- Acronym
- BV
- Status last verified
- Aug 2011
- First submitted
- 8 Aug 2011
- Last updated
- 23 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Courses of Lactobacilli Treatment on Bacterial Vaginosis and Related Pregnancy Outcomes
- ClinicalTrials.gov ID
- NCT01421615
- Acronym / sponsor ID
- BV / GZ board of health
- Conditions
- Bacterial Vaginosis
- Keywords
- Bacterial vaginosis, Probiotics, Lactobacilli, Pregnancy outcome, Randomized controlled trial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital, Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Ministry of Health, China
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 23 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the effect of lactobacillus preparation on Bacterial vaginosis (BV) in low-risk pregnant women and to evaluate the value of double courses for the patients with durative positive result. It is assumed that the living preparation of lactobacillus was beneficial for treatment of BV during pregnancy. The two-courses treatment can increase the response rate and improve pregnancy outcomes in the durative BV positive patients comparing with one-course one.
Detailed description
Research method: This was a single-blind randomized controlled trial.
Diagnostic standard: The study population is the women who have positive outcome of screened test for BV by sialidase method.
Allocation and follow up: Patients who were screened for BV by sialidase method and randomly allocated into control group、one-course group and two-course group. The patients in control group who were BV positive would receive lotion washout and be repeatedly evaluated BV status per two weeks and be followed up to the 4th～7th days of postpartum. The patients in one-course group and in two-course group who were BV positive would receive the first course treatment of vaginal lactobacillus capsule and be repeatedly evaluated BV status after treatment. The patients in two-course group will receive the second course treatment of Lactobacilli preparation if their BV test result were still positive after one-course treatment, but those in one-course group would NOT receive any treatment even though they would have the durative BV positive result after one-course of Lactobacilli. The patients in the two interventional groups would be repeatedly evaluated BV status at 28th gestational weeks and be followed up to the 4th-7th days of postpartum. All the inspection results of vaginal secretions and pregnancy outcome were recorded.
Outcome measures:
- The prevalence of BV,the response rates of lactobacillus preparation,the recurrence rate.
- The adverse pregnancy outcomes of mother.
- The adverse pregnancy outcomes of perinatal fetus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| lotion | Placebo comparator | Drug: Vaginal capsules of lactobacillilotion:the patients in control group receive washing medicine and are followed up to the 4rd～7th days of postpartum. |
| lactobacilli capsule | Experimental | Drug: Vaginal capsules of lactobacilli |
| lactobacilli capsules | Experimental | Drug: Vaginal capsules of lactobacilli |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- pregnant women at 16-18 gestational weeks with no history of premature labor or premature rupture of fetal membranes.
Key exclusion criteria (6 listed)
- who have menstrual disorder or forget the last menstrual period, and have no type-B ultrasonic result, so the gestational week is not clear.
- Who have monilial vaginitis, trichomonas vaginitis, or sexual transmitted diseases.
- who have severe medicochirurgic diseases.
- multiple pregnancy.
- anomalies of genital tract
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal capsules of lactobacilliAlso: Brand names: Dingjunsheng, Commodity code name: A246912309879, Approved by the state: S20030005The patients in one-course group who were BV positive would receive the first course treatment of vaginal lactobacillus capsule and be repeatedly evaluated BV status after treatment. If their BV test result were still positive after one-course treatment, they would NOT receive any treatment but would be followed up to the 4th-7th days of postpartum. | Drug | lactobacilli capsule, lactobacilli capsules, lotion |
| Vaginal capsules of lactobacilliAlso: Brand names: Dingjunsheng, Commodity code name: A246912309879, Approved by the state: S20030005The patients in two-course group who were BV positive would receive the first course treatment of vaginal lactobacillus capsule and be repeatedly evaluated BV status after treatment. If their BV test result were still positive after one-course treatment, they will receive the second course treatment of Lactobacilli preparation. | Drug | lactobacilli capsule, lotion |
Primary outcome
Number of Participants who transformed to negative status of bacterial vaginosis
Time frame: 6 months
The patients who were BV positive would receive treatment and be repeatedly evaluated BV status on the time of post-treatment 1 week, 28th gestational weeks, and before birth, respectively.The number of Participants who transformed to negative status of bacterial vaginosis will be recorded. The rates of bacterial vaginosis transformed to negative status will be calculated.
3 secondary outcomes
pregnancy outcome of mother
Time frame: 6 months (from 16~18 gestational weeks to the 4th-7th days of postpartum)
pregnancy outcome of perinatal fetus
Time frame: 6 months (from 16~18 gestational weeks to the 4th-7th days of postpartum)
Safety and tolerability
Time frame: 6 months (from 16~18 gestational weeks to the 4th-7th days of postpartum)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanfang Lee, Master principal investigator
The First Affiliated Hospital of Guangzhou University of TCM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vaginal capsules of lactobacilli in people with Bacterial Vaginosis, run by The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine at 1 site in China.
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 6 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 23 Aug 2011. 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 China. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Yanfang LEE (13928777126, 13928777126@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants who transformed to negative status of bacterial vaginosis (time frame: 6 months). 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 23 Aug 2011.