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OpenTrials
Completed

NCT Number: NCT07364383

Probiotics for Women

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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Key information

Conditions

Probiotic Microbiome Wellbeing

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Comac Medical, Sofia,

Sofia, Bulgaria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Placebo

Other

MCC alone

Primary outcomes

  1. Changes in wellbeing through the use of wellbeing diaries

    Time frame: From date of randomization until the end of the intervention period (20 days)

    Changes in wellbeing and in the composition of the microbiome

  2. Changes in microbiome composition through shotgun Metagenomics

    Time frame: From date of randomization until the end of the intervention period (20 days)

Sponsors and collaborators

Lead sponsor

Cultech Ltd

Industry

Registry information

Official study title

Microbiome and Wellbeing Modulation in Women: An Exploratory Probiotic Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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