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Investigation into the effect of probiotic supplementation on the wellbeing of women with a history of vaginal discomfort and/or irritation, along with any microbiome changes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | Lab4 Multi-strain Probiotic + Lactobacillus gasseri and Lactobacillus crispatus (comprising Lactobacilli and bifidobacteria species) with Vitamin A and Vitamin D |
|
| Placebo | Placebo Comparator | Matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lab4 + Lactobacillus gasseri and Lactobacillus crispatus | Dietary Supplement | Lactobacillus acidophilus CUL-60, Lactobacillus acidophilus CUL-21, Lactobacillus gasseri CUL-09, Lactobacillus crispatus LCR15, Bifidobacterium bifidum CUL-20 and Bifidobacterium animalis subsp. lactis CUL-34 at a dose of 20 billion bacteria per/ day combined with vitamin A (800 IU/day) and Vitamin D (1000 IU/day) on a microcrystaline cellulose (MCC) base Daily dose: 20 billion bacteria per day |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in wellbeing through the use of wellbeing diaries | Changes in wellbeing and in the composition of the microbiome | From date of randomization until the end of the intervention period (20 days) |
| Changes in microbiome composition through shotgun Metagenomics | From date of randomization until the end of the intervention period (20 days) |
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Inclusion Criteria:
Exclusion Criteria:
Female
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comac Medical, Sofia, | Sofia | Bulgaria |
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| Placebo | Other | MCC alone |
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