Bacterial VaginosisPhase 1NCT04638257
Role of Oral Lactobacilli on Vaginal Flora of Pregnant Women
A Phase 1 study testing Lactobacilli rhamnosus GR-1 and Lactobacilli fermentum RC-14 in people with Bacterial Vaginosis, run by The University of Texas Medical Branch, Galveston.
Trial summary
Bacterial vaginosis (BV) occurs in about 20% of pregnancies and responsible for up to 25% of visits to gynecological clinics. BV is characterized by a shift in vaginal bacterial flora from lactobacilli to pathogenic bacterial flora like Gardnerella and Mycoplasma. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- Lactobacilli rhamnosus GR-1 and Lactobacilli fermentum RC-14
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Mar 2015
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant women <18 weeks gestational age
- >18 years old and able provide informed consent
- No clinical bacterial vaginosis requiring anti-microbial treatment
- BV Blue test positive on screening
- Planned or probable delivery at UTMB, Galveston
Who cannot join
- Taking antibiotics or any other microbial at the time of recruitment
- Documented need for cervical cerclage
- Multi fetal pregnancy
- Known aneuploidy or lethal fetal anomalies
- Illicit drug use
- Serious maternal medical conditions
Show all 20Show fewer
- Renal insufficiency with serum creatinine >1.5, known proteinuria >300mg/24 hours or receiving dialysis.
- Chronic liver disease with liver transaminases >2 times the upper limit of the normal range
- Organ transplant recipients.
- Severe pulmonary disorder (such as significant obstructive/restrictive disorder, pulmonary hypertension, cystic fibrosis, and chronic oxygen requirement).
- Severe heart disease (such as cardiomyopathy with decreased left ventricular ejection fraction, obstructive valvular disease, replaced heart valve, uncorrected aortic coarctation or tetrology).
- Established lupus anticoagulant syndrome or antiphospholipid syndrome).
- Diabetes class C and greater
- Chronic conditions requiring medications for control (such as chronic hypertension, SLE, inflammatory bowel disease, and asthma).
- Acquired Immunodeficiency Syndrome or HIV infection without AIDS.
- Medical complications of pregnancy
- Pre-eclampsia
- Thrombophilia
- Pregnancy induced hypertension
- Gestational diabetes
About this study
Official title: A Phase I, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Effects of Probiotic Lactobacilli on Vaginal Flora of Pregnant Women
Bacterial vaginosis (BV) occurs in about 20% of pregnancies and responsible for up to 25% of visits to gynecological clinics. BV is characterized by a shift in vaginal bacterial flora from lactobacilli to pathogenic bacterial flora like Gardnerella and Mycoplasma. Risk factors for the development of BV include douching, use of intrauterine contraceptive devices, new or multiple sexual partners, smoking and African American background.
Read the detailed description
Diagnosis of BV based on Amsel's criteria and Nugent's scoring. In Amsel's criteria include: presence of thin vaginal discharge, clue cells, vaginal fluid pH >4.5 and positive whiff test. The Nugent score is derived from gram-stained vaginal smear; yielding a score between 0 - 10. A score of, 4 is normal, 4 - 6 is intermediate and a score >7 represents BV. CDC recommends diagnosis of BV on the presence of >3 Amsel criteria and a Nugent score >7. FDA recommends, verification of BV cure should be conducted 21 - 30 days after the initiation of therapy (absence of Amsel's criteria and Nugent score <4).
Cure rate of BV with conventional anti-microbial agents have been disappointing due to high recurrence rate of BV. Recurrence of BV results in repeated exposure to anti-microbial agents which may lead to emergence of drug-resistance strains \& the potential for adverse reactions. This suggests a need for alternative therapeutic measures of BV.
Lactobacilli rhamnosus GR-1 and Lactobacilli fermentum RC-14 are H2O2 producing lactobacilli which are toxic to bacteria causing BV by antagonizing the growth and adhesion of pathologic bacteria causing BV. In non-pregnant women, oral administrations of these strains of lactobacilli are safe, and reduce the risk of BV by restoring predominant lactobacilli, the normal vaginal bacterial flora.
Bacterial vaginosis is associated with increased incidence of preterm delivery. For pregnant women, restoration of lactobacilli in the genital tract could be very important to prevent BV and may lower the risk of preterm labor. At present, the safety, tolerability and efficacy of lactobacilli use during pregnancy is not well known for the fetus and the pregnant women. The investigators plan to do a phase I trial to evaluate the safety, tolerability, and efficacy of oral lactobacilli on vaginal flora of pregnant women and follow up their infants for any side effect up to 6 months of age.
In summary, treatment failure and recurrence of BV following anti-microbial treatment is frustrating. During pregnancy, probiotics may be the next step to treat BV and restore normal vaginal micro flora. But the safety of lactobacilli use during pregnancy is not established. The investigators will do phase I trial to evaluate safety of oral lactobacilli in pregnant women along with their infants up to 6 months.
- Conditions
- Bacterial Vaginosis
- Being tested
- Lactobacilli rhamnosus GR-1 and Lactobacilli fermentum RC-14, 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.
Lactobacilli rhamnosus GR-1 and Lactobacilli fermentum RC-14Biological
Daily oral Lactobacilli starting at =<18 weeks of gestation in singleton pregnancy
PlaceboOther
Daily oral placebo starting at =<18 weeks of gestation in singleton pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Lactobacilli | Experimental | Lactobacilli rhamnosus GR-1 and Lactobacilli fermentum RC-14 Lactobacilli rhamnosus GR-1 and Lactobacilli fermentum RC-14 Receives: Biological: Lactobacilli rhamnosus GR-1 and Lactobacilli fermentum RC-14 |
| Placebo | Placebo comparator | Receives placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
This number will determine if oral supplementation of lactobacilli is safe and tolerated by pregnant women.
Measured: Pregnancy (<18 weeks gestation) for 60 days
Secondary outcomes (3)
Number of participants with incidence and severity of Bacterial Vaginosis during pregnancy assessing for positive lab results screening for Bacterial Vaginiosis
- BV Blue test
- Nugent scoring
- Amsel clinical criteria
Measured: baseline up until 8 (after starting the study drug)
Number of Preterm deliveries
Preterm delivery (<37 weeks gestation)
Measured: baseline up until 36 weeks gestation
Measure the inflammatory markers in the vaginal secretions
- IL1β
- IL6
- IL8
- TNF-α
- GmCSF
Measured: baseline up until 8 (after starting the study drug)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study startJan 2013
- Primary completionMar 2015
- Study completionMar 2015
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.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sunil K Jain, MD, Principal investigator, The University of Texas Medical Branch, Galveston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638257
- Sponsor's protocol ID
- 12-239
- Status last verified
- Nov 2020
- First submitted
- 5 Oct 2015
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Effects of Probiotic Lactobacilli on Vaginal Flora of Pregnant Women
- ClinicalTrials.gov ID
- NCT04638257
- Acronym / sponsor ID
- 12-239
- Conditions
- Bacterial Vaginosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 20 Nov 2020 (actual)
- 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 (BV) occurs in about 20% of pregnancies and responsible for up to 25% of visits to gynecological clinics. BV is characterized by a shift in vaginal bacterial flora from lactobacilli to pathogenic bacterial flora like Gardnerella and Mycoplasma. Risk factors for the development of BV include douching, use of intrauterine contraceptive devices, new or multiple sexual partners, smoking and African American background.
Detailed description
Diagnosis of BV based on Amsel's criteria and Nugent's scoring. In Amsel's criteria include: presence of thin vaginal discharge, clue cells, vaginal fluid pH >4.5 and positive whiff test. The Nugent score is derived from gram-stained vaginal smear; yielding a score between 0 - 10. A score of, 4 is normal, 4 - 6 is intermediate and a score >7 represents BV. CDC recommends diagnosis of BV on the presence of >3 Amsel criteria and a Nugent score >7. FDA recommends, verification of BV cure should be conducted 21 - 30 days after the initiation of therapy (absence of Amsel's criteria and Nugent score <4).
Cure rate of BV with conventional anti-microbial agents have been disappointing due to high recurrence rate of BV. Recurrence of BV results in repeated exposure to anti-microbial agents which may lead to emergence of drug-resistance strains \& the potential for adverse reactions. This suggests a need for alternative therapeutic measures of BV.
Lactobacilli rhamnosus GR-1 and Lactobacilli fermentum RC-14 are H2O2 producing lactobacilli which are toxic to bacteria causing BV by antagonizing the growth and adhesion of pathologic bacteria causing BV. In non-pregnant women, oral administrations of these strains of lactobacilli are safe, and reduce the risk of BV by restoring predominant lactobacilli, the normal vaginal bacterial flora.
Bacterial vaginosis is associated with increased incidence of preterm delivery. For pregnant women, restoration of lactobacilli in the genital tract could be very important to prevent BV and may lower the risk of preterm labor. At present, the safety, tolerability and efficacy of lactobacilli use during pregnancy is not well known for the fetus and the pregnant women. The investigators plan to do a phase I trial to evaluate the safety, tolerability, and efficacy of oral lactobacilli on vaginal flora of pregnant women and follow up their infants for any side effect up to 6 months of age.
In summary, treatment failure and recurrence of BV following anti-microbial treatment is frustrating. During pregnancy, probiotics may be the next step to treat BV and restore normal vaginal micro flora. But the safety of lactobacilli use during pregnancy is not established. The investigators will do phase I trial to evaluate safety of oral lactobacilli in pregnant women along with their infants up to 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacilli | Experimental | Biological: Lactobacilli rhamnosus GR-1 and Lactobacilli fermentum RC-14Lactobacilli rhamnosus GR-1 and Lactobacilli fermentum RC-14 Lactobacilli rhamnosus GR-1 and Lactobacilli fermentum RC-14 |
| Placebo | Placebo comparator | Other: PlaceboReceives placebo |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Pregnant women <18 weeks gestational age
- >18 years old and able provide informed consent
- No clinical bacterial vaginosis requiring anti-microbial treatment
- BV Blue test positive on screening
- Planned or probable delivery at UTMB, Galveston
Key exclusion criteria (20 listed)
- Taking antibiotics or any other microbial at the time of recruitment
- Documented need for cervical cerclage
- Multi fetal pregnancy
- Known aneuploidy or lethal fetal anomalies
- Illicit drug use
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 |
|---|---|---|
| Lactobacilli rhamnosus GR-1 and Lactobacilli fermentum RC-14Daily oral Lactobacilli starting at =<18 weeks of gestation in singleton pregnancy | Biological | Lactobacilli |
| PlaceboDaily oral placebo starting at =<18 weeks of gestation in singleton pregnancy | Other | Placebo |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Pregnancy (<18 weeks gestation) for 60 days
This number will determine if oral supplementation of lactobacilli is safe and tolerated by pregnant women.
3 secondary outcomes
Number of participants with incidence and severity of Bacterial Vaginosis during pregnancy assessing for positive lab results screening for Bacterial Vaginiosis
Time frame: baseline up until 8 (after starting the study drug)
Number of Preterm deliveries
Time frame: baseline up until 36 weeks gestation
Measure the inflammatory markers in the vaginal secretions
Time frame: baseline up until 8 (after starting the study drug)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Individual participant dataSharing planned: No
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)
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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)
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A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
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Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
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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.
Sunil K Jain, MD principal investigator
The University of Texas Medical Branch, Galveston
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lactobacilli rhamnosus GR-1 and Lactobacilli fermentum RC-14 in people with Bacterial Vaginosis, run by The University of Texas Medical Branch, Galveston.
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 5 inclusion and 20 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: finished, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: Pregnancy (<18 weeks gestation) for 60 days). 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 Nov 2020.