The purpose of this study was to determine whether L. rhamnosus GR-1 and L. reuteri RC-14 delivered via capsules to the vagina of post-menopausal women over a three day course of treatment can restore and maintain a lactobacilli-dominated microbiota. Exploratory analysis of microbial ecology, human microarrays and multiplex immunological assessments are included to characterize potential effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
14
L. rhamnosus GR-1 and L. reuteri RC-14 capsules manufactured by Chr. Hansen
Placebo Comparator capsules, identical in appearance to the active product; 98% Gelatin with no L. rhamnosus GR-1 and L. reuteri RC- 14.
Dorli Herman
London, Ontario, Canada
Change from baseline Nugent Score (arbitrary units) after treatment versus Change from baseline Nugent Score after placebo
Determine whether L. rhamnosus GR-1 and L. reuteri RC-14 delivered via capsules to the vagina of post-menopausal women over a three day course of treatment can restore and maintain a lactobacilli-dominated microbiota for one week as measured by a decrease in the Nugent Scores from an intermediate score (4 - 6) at baseline to a normal score (0 - 3) following treatment compared to a placebo.
Time frame: Baseline Days 15 & 36, post treatment/control Days 19 & 40
Percent Lactobacilli abundance
Change in lactobacilli abundance before and after probiotic treatment and before and after placebo treatment. Lactobacilli abundance will be calculated as percentage of number of lactobacilli taxon divided by the total number of taxons.
Time frame: Untreated (Days 1, 5, & 15), Baseline Treatment I (Days15), Treatment I (Days 19 & 26), Baseline Treatment II (Day 36), Treatment II (Days 40 & 47)
Change in presence of metabolites
Gas chromatography-mass spectrometry will be used to determine changes in metabolites (such as lactate, glutamic acid, and others) before and after probiotic and placebo treatments.
Time frame: Untreated (Days 1, 5, & 15), Baseline Treatment I (Days15), Treatment I (Days 19 & 26), Baseline Treatment II (Day 36), Treatment II (Days 40 & 47)
Change in cytokine/chemokine levels
Multiplex ELISA based assay will be used to evaluate the modulation of cytokine and chemokine levels known regulate inflammation and host defense response before and after probiotic and placebo treatment.
Time frame: Untreated (Days 1, 5, & 15), Baseline Treatment I (Days15), Treatment I (Days 19 & 26), Baseline Treatment II (Day 36), Treatment II (Days 40 & 47)
Change in global host gene expression
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Microarray analysis using GeneChip Human 2.0 ST array will be used to measure gene expression changes (by mRNA analysis) to determine whether there are differences in gene regulation between probiotic, placebo, and no treatment conditions.
Time frame: Untreated (Days 1, 5, & 15), Baseline Treatment I (Days15), Treatment I (Days 19 & 26), Baseline Treatment II (Day 36), Treatment II (Days 40 & 47)
Change in self-reported vaginal symptoms
Symptom analysis to evaluate whether probiotic treatment is associated with symptom relief.
Time frame: Untreated (Days 1, 5, & 15), Baseline Treatment I (Days15), Treatment I (Days 19 & 26), Baseline Treatment II (Day 36), Treatment II (Days 40 & 47)