Microbiome, Probiotic, Wellbeing
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTLab4 + Lactobacillus gasseri and Lactobacillus crispatus
Lactobacillus acidophilus CUL-60, Lactobacillus acidophilus CUL-21, Lactobacillus gasseri CUL-09, Lactobacillus crispatus CUL40, 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
OTHERPlacebo
MCC alone
Sponsors
Cultech Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy menstruating women (female at birth), 18 to 40 years old with history of 3 or 4 episodes of vaginal discomfort (1 or more days) involving itching, burning sensation and/or odorous discharge in the past 12 months 2. Willing to start on completion of monthly cycle (\< 5 days post completion) 3. Willing to provide vaginal and faecal samples 4. Willing to maintain normal diet and lifestyle during the study 5. Willing to refrain from taking other probiotic supplements during the study 6. Willing to refrain from sexual activity, the use of lubricants and vaginal cleaning (with antibacterials)/douching for 2 days prior to providing vaginal swabs
Exclusion criteria
1. Consumption of oral antibiotics within the last 2 months 2. Given birth in the last 3 months, currently pregnant or planning pregnancy 3. Currently experiencing (symptoms of) a vaginal or urinary infection 4. Immunodeficient or undergoing immunosuppressive therapy 5. Diagnosed with diabetes/cardiovascular disease/cancer/dementia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in wellbeing through the use of wellbeing diaries | From date of randomization until the end of the intervention period (20 days) | Changes in wellbeing and in the composition of the microbiome |
| Changes in microbiome composition through shotgun Metagenomics | From date of randomization until the end of the intervention period (20 days) | — |
Countries
Bulgaria
Outcome results
None listed