The Association Between the Transfer of Lactobacilli From the Gastrointestinal Tract to the Vagina and the Prevention / Eradication of Abnormal Vaginal Flora in High Risk Pregnancies
NCT ID: NCT02430246
Last Updated: 2019-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
40 participants
INTERVENTIONAL
2016-01-31
2019-01-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Patient with a positive smear for AVF- patients tested positive will be treated with either clindamycin or metronidazole. Following treatment another smear will be taken according to which the patients will be divided into 2 research groups: (1) Assessing the effectiveness of probiotic formula to prevent AVF re-infection (secondary infection) - this group includes patients with normal vaginal flora following antibiotic administration. (2) Assessing the effectiveness of probiotic formula to eradicate AVF - this group includes patients with persistent AVF following antibiotic administration (first and second line). In each group the patients will be divided into a research group which will receive the probiotic formula UREX PLUS (containing L. rhamnosus GR-1and L. reuteri RC-14) and a control group which will receive a placebo twice a day until 36.6 weeks of gestation.
Patient with a negative smear for AVF - in those patients the effectiveness of probiotic formula will be tested for primary prevention. These patients will be divided into a research group which will receive the probiotic formula UREX PLUS and a control group which will receive a placebo twice a day until 36.6 weeks of gestation.
Finally, the colonization of lactobacilli in the vaginal flora will be examined by dividing patients with normal vaginal flora into one group receiving a probiotic capsule containing L. rhamnosus GR-1 and L. reuteri RC-14 twice a day for 2 months and a second group without intervention. After two months the group receiving probiotic capsule will receive no treatment and the second group will receive probiotic capsule containing L. rhamnosus GR-1and L. reuteri RC-14 twice a day for 2 months.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Primary prevention - Urex Plus
Patients with Normal vaginal flora in the experimental arm will be treated with UREX PLUS
Urex Plus
Probiotic
Primary prevention - Placebo
Patients with Normal vaginal flora in the Placebo arm will be treated with a capsule without active ingredient
Placebo
capsule without active ingredient
Secondary prevention - Urex Plus
Patients with abnormal vaginal flora in the experimental arm will be treated with antibiotic (either clindamycin, metronidazole or both if one was not effective), Once AVF/BV was eradicated, the patient will be given UREX PLUS
Urex Plus
Probiotic
Secondary prevention - Placebo
Patients with abnormal vaginal flora in the Placebo arm will be treated with antibiotic (either clindamycin, metronidazole or both if one was not effective), Once AVF/BV was eradicated, the patient will be given placebo without active ingredient
Placebo
capsule without active ingredient
Eradication - Urex Plus
Patients with persistent abnormal vaginal flora following treatment with clindamycin and metronidazole in the experimental arm will be treated with UREX PLUS
Urex Plus
Probiotic
Eradication - Placebo
Patients with persistent abnormal vaginal flora following treatment with clindamycin and metronidazole in the placebo arm will be treated with placebo without active ingredient
Placebo
capsule without active ingredient
Lactobacilli transfer - probiotic capsule
Patients with Normal vaginal flora will be treated with a probotic capsule containing L. rhamnosus GR-1and L. reuteri RC-14 for two months afterwhich they will receive no treatment for additional two months. Lactobacili colonization in the vaginal flora will be tested
Probotic capsule containing L. rhamnosus GR-1and L. reuteri RC-14
Lactobacilli transfer - probiotic capsule after 2 months
Patients with Normal vaginal flora will be followed for two months without intervention afterwhich they will receive a probotic capsule containing L. rhamnosus GR-1and L. reuteri RC-14 for two months. Lactobacili colonization in the vaginal flora will be tested.
Probotic capsule containing L. rhamnosus GR-1and L. reuteri RC-14
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Urex Plus
Probiotic
Placebo
capsule without active ingredient
Probotic capsule containing L. rhamnosus GR-1and L. reuteri RC-14
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Immunocompromised women
* Planned elective preterm birth for reasons other than preterm premature rupture of membranes
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
HaEmek Medical Center, Israel
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
enav yefet
MD/PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
ENAV YEFET, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
HaEmek Medical Center , Afula
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
HaEmek Medical Center
Afula, , Israel
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0096-13
Identifier Type: -
Identifier Source: org_study_id