Probiotics for Women

NCT07364383 | Not Yet Recruiting

• 1 other identifier: MMS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Probiotic; Microbiome; Wellbeing

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (2)

Active

ACTIVE COMPARATOR

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

Dietary Supplement: Lab4 + Lactobacillus gasseri and Lactobacillus crispatus

Placebo

PLACEBO COMPARATOR

Matching placebo

Other: Placebo

Interventions

Placebo OTHER

MCC alone

Placebo

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

Active

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Willing to start on completion of monthly cycle (\< 5 days post completion)
• Willing to provide vaginal and faecal samples
• Willing to maintain normal diet and lifestyle during the study
• Willing to refrain from taking other probiotic supplements during the study
• Willing to refrain from sexual activity, the use of lubricants and vaginal cleaning (with antibacterials)/douching for 2 days prior to providing vaginal swabs

You may not qualify if:

• Consumption of oral antibiotics within the last 2 months
• Given birth in the last 3 months, currently pregnant or planning pregnancy
• Currently experiencing (symptoms of) a vaginal or urinary infection
• Immunodeficient or undergoing immunosuppressive therapy
• Diagnosed with diabetes/cardiovascular disease/cancer/dementia

Sponsors & Collaborators

• Cultech Ltd: lead

Study Sites (1)

Comac Medical, Sofia,

Sofia, Bulgaria

Location

Central Study Contacts

Maya Dabcheva

CONTACT

+359887113036; maya.dabcheva@comac-medical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 23, 2026
• Study Start: January 9, 2026
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

BU (1)