Bacterial VaginosisPhase 4NCT01558388
Probiotic Versus Placebo as Adjuvant for Bacterial Vaginosis Treatment During Pregnancy
A Phase 4 study testing Lactobacillus acidophilus in people with Bacterial Vaginosis, run by Università degli Studi di Brescia at 1 site in Italy.
Trial summary
Bacterial vaginosis is a common vaginal condition involving a reduction in the amount of Lactobacilli, the normal bacteria colonizing the vagina, and an overgrowth of pathogenic bacteria. The presence of bacterial vaginosis in pregnancy is associated with an increased risk of preterm delivery. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- Lactobacillus acidophilus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2009to Dec 2012
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- singleton pregnancy
- gestational age 12-32 weeks
- diagnosis of bacterial vaginosis
- treatment of bacterial vaginosis with oral clindamycin 300 mg, twice-daily for 7 days
Who cannot join
- multiple pregnancy
- allergy to clindamycin
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ostetricia 1, Azienda Ospedaliera Spedali Civili di Brescia
Brescia, 25123
Luana Danti, MD, +390303995365
About this study
Official title: Randomised Control Trial of Probiotics Versus Placebo as Adjuvant to Oral Clindamycin Treatment for Bacterial Vaginosis During Pregnancy
Bacterial vaginosis is a common vaginal condition involving a reduction in the amount of Lactobacilli, the normal bacteria colonizing the vagina, and an overgrowth of pathogenic bacteria. The presence of bacterial vaginosis in pregnancy is associated with an increased risk of preterm delivery. After a course of antibiotic treatment, recurrence of bacterial vaginosis has been reported in 10-70% of cases. This study aims to verify if administration of vaginal Lactobacilli may reduce the occurrence rate after antibiotic treatment of bacterial vaginosis during pregnancy.
- Conditions
- Bacterial Vaginosis
- Being tested
- Lactobacillus acidophilus, Placebo
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus acidophilusDrug
Also called Pregyn-S
Lactobacillus acidophilus 500 million colony-forming units/tablets. One vaginal tablet daily for 10 days.
PlaceboDrug
One vaginal tablet daily for 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Vaginal lactobacilli | Experimental | Not described Receives: Drug: Lactobacillus acidophilus |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal lactobacillus recolonization
Measured: 3-5 weeks
Recurrence rate of bacterial vaginosis
Measured: 3-5 weeks
Secondary outcomes (1)
Preterm delivery <37 weeks
Measured: within 43 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study startSep 2009
- Primary completionDec 2012 (estimated)
- Study completionDec 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Brescia
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Responsible party
- Principal investigator, Federico Prefumo, Università degli Studi di Brescia
- Investigators
- Luana Danti, MD, Principal investigator, Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaAndrea Lojacono, MD, Principal investigator, Università degli Studi di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01558388
- Sponsor's protocol ID
- Spedali Civili 926
- Status last verified
- Mar 2012
- First submitted
- 15 Mar 2012
- Last updated
- 20 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Control Trial of Probiotics Versus Placebo as Adjuvant to Oral Clindamycin Treatment for Bacterial Vaginosis During Pregnancy
- ClinicalTrials.gov ID
- NCT01558388
- Acronym / sponsor ID
- Spedali Civili 926
- Conditions
- Bacterial Vaginosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Università degli Studi di BresciaUniversity, hospital or other
- Collaborators
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Study start
- Sep 2009
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 20 Mar 2012 (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.
Bacterial vaginosis is a common vaginal condition involving a reduction in the amount of Lactobacilli, the normal bacteria colonizing the vagina, and an overgrowth of pathogenic bacteria. The presence of bacterial vaginosis in pregnancy is associated with an increased risk of preterm delivery. After a course of antibiotic treatment, recurrence of bacterial vaginosis has been reported in 10-70% of cases. This study aims to verify if administration of vaginal Lactobacilli may reduce the occurrence rate after antibiotic treatment of bacterial vaginosis during pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal lactobacilli | Experimental | Drug: Lactobacillus acidophilus |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- singleton pregnancy
- gestational age 12-32 weeks
- diagnosis of bacterial vaginosis
- treatment of bacterial vaginosis with oral clindamycin 300 mg, twice-daily for 7 days
Key exclusion criteria (2 listed)
- multiple pregnancy
- allergy to clindamycin
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 |
|---|---|---|
| Lactobacillus acidophilusAlso: Pregyn-SLactobacillus acidophilus 500 million colony-forming units/tablets. One vaginal tablet daily for 10 days. | Drug | Vaginal lactobacilli |
| PlaceboOne vaginal tablet daily for 10 days. | Drug | Placebo |
Primary outcome
Vaginal lactobacillus recolonization
Time frame: 3-5 weeks
Recurrence rate of bacterial vaginosis
Time frame: 3-5 weeks
1 secondary outcome
Preterm delivery <37 weeks
Time frame: within 43 weeks of gestation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2012.
Related trials for Bacterial Vaginosis
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 2
WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
RecruitingPhase 1
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
Randomized, Open-label
Not yet recruitingPhase 1
A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
Bacterial Vaginosis
Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Bacterial Vaginoses
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.
Luana Danti, MD principal investigator
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Andrea Lojacono, MD principal investigator
Università degli Studi di Brescia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lactobacillus acidophilus in people with Bacterial Vaginosis, run by Università degli Studi di Brescia at 1 site in Italy.
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 4 inclusion and 2 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 20 Mar 2012. 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 Italy. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal lactobacillus recolonization (time frame: 3-5 weeks). The study lists 2 primary outcomes in all. 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 20 Mar 2012.