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NCT05688397
Evaluation of the Vaginal Colonization of Two New Lactobacillus Strains After Oral Administration in Healthy Volunteers
Conditions: Healthy
Sex: Female
Ages: 18 Years – 45 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 48
Sponsor: AB Biotics, SA
Location: Spain
Summary
Randomized study to determine whether the vaginally isolated strains of Lactobacillus gasseri and/or Lactobacillus crispatus can colonize the vagina when taken orally for 18 days.
Secondary outcomes comprise evaluation of safety, tolerability, impact on vaginal microbiota and vaginal pH
Eligibility Criteria
Inclusion Criteria:Healthy womenReproductive age 18-45 yearsExclusion Criteria:Vaginal infection or symptoms (AMSEL criteria).Relevant disease (immunodeficiency, cervicovaginal pathology, diabetes, estrogen-dependent tumors, inflammatory bowel disease, atrophic vaginitis, pancreatitis)Suffer from chronic diarrhea or constipation or short bowel syndrome,Having taken systemic or vaginal antibiotics or antifungals during the month prior to study entry.Pregnant women or willing to be during the study, lactating women.Having taken another probiotic during the month prior to study entry orally or vaginally.
This includes food supplements or foods supplemented with probiotics such as Actimel, Activia or similar.Intake of immunomodulators or systemic corticosteroids.History of alcohol or drug abuse.Menopausal women.Use of the IUD.Use of spermicides or vaginal lubricants during the month prior to study entry.Very irregular periods or low probability of going at least 18 days without menstruation (short cycles).Have participated in a clinical trial during the month prior to entering the study.Not being able to follow or understand study procedures.
This includes not being willing to maintain sexual abstinence during the 24 hours prior to each vaginal sample collection.Any other condition not compatible with the study according to the investigators
Source: ClinicalTrials.gov (NCT05688397). StuddyBuddy aggregates publicly available trial information.