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Completed
NCT07364383
Probiotics for Women
Conditions: Probiotic, Microbiome, Wellbeing
Sex: Female
Ages: 18 Years – 40 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 40
Sponsor: Cultech Ltd
Location: Comac Medical, Sofia, Sofia
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07364383). StuddyBuddy aggregates publicly available trial information.