Probiotics for Women

Cultech

Status: Not yet enrolling

Conditions: Wellbeing; Microbiome; Probiotic

Treatments: Dietary Supplement: Lab4 + Lactobacillus gasseri and Lactobacillus crispatus; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07364383

MMS

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Active

Active Comparator group

Description:

Lab4 Multi-strain Probiotic + Lactobacillus gasseri and Lactobacillus crispatus (comprising Lactobacilli and bifidobacteria species) with Vitamin A and Vitamin D

Treatment:

Dietary Supplement: Lab4 + Lactobacillus gasseri and Lactobacillus crispatus

Placebo

Placebo Comparator group

Description:

Matching placebo

Treatment:

Other: Placebo