Vaginal microbiota is abundantly colonized by Lactobacillus genera. When vaginal microbiota gets altered, opportunistic microorganisms may proliferate and become abundant species giving rise to dysbiosis. Probiotics are living organisms that provide the host certain benefits. Despite probiotics have been historically linked to intestinal microbiota, several research groups have published positive results for some Lactobacillus strains in vaginal microbiota. The Lactobacillus strain investigated in the presented project showed the ability to prevent recurrent vaginal Candidiasis in women with high vaginal candidiasis prevalence. Nowadays the Lactobacillus strain here investigated is commercialized as vaginal caps, however oral intake is widely preferred among consumers. Because of that, this study aims to determine whether this Lactobacillus strain is able to colonize vaginal microbiota when administered orally.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
30
Oral food supplement
Sta María del Rosell university hospital
Cartagena, Spain
Colonization
Determine the relative presence of Lactobacillus plantarum in vaginal microbiota by metagenomic analysis
Time frame: change day 14-23 from baseline
Colonization
Determine the relative presence of Lactobacillus plantarum in vaginal microbiota by metagenomic analysis
Time frame: change day 42 from baseline
Lactobacillary grade (LBG) score
obtained by cytology analysis by pathologists and calculated according to Donders et al., 2002. Higher scores imply more severe conditions. Scale ranges from 1 to 3.
Time frame: change day 42 from baseline
Other bacteria in vagina
Detection of other bacteria by metagenomic analysis
Time frame: change day 14-23 from baseline
Other bacteria in vagina
Detection of other bacteria by metagenomic analysis
Time frame: change day 42 from baseline
Vaginal pH
Measured through urine test strip
Time frame: Change day 14-23 from baseline
Vaginal pH
Measured through urine test strip
Time frame: Change day 42 from baseline
Product satisfaction
Measured with a categorical scale (Likert type) going from 0 to 5 . Where 0 is very insatisfied and 5 is very satisfied
Time frame: day 14-23
Safety and tolerability
Analyzed by the number of adverse events registered during the study
Time frame: through study completion, an average of 42 days
Gastrointestinal symptoms
Analyzed by the validated Spanish translation of Gastrointestinal Symptom Rating Scale (GSRS) according to Kulich et al., 2005. Score ranges from 0 to 90 where 0 is no symptoms at all and 90 is the highest severity in all symptoms assessed (e.g. pain, bloating, etc)
Time frame: Change day 14-23 from baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.