Probiotics for Women

January 21, 2026 updated by: Cultech Ltd

Microbiome and Wellbeing Modulation in Women: An Exploratory Probiotic Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Matching placebo
Other: Placebo
MCC alone
Active Comparator: Active
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From date of randomization until the end of the intervention period (20 days)
Changes in microbiome composition through shotgun Metagenomics
Time Frame: From date of randomization until the end of the intervention period (20 days)
From date of randomization until the end of the intervention period (20 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cultech Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 9, 2026

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

January 21, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • MMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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