ProbioticNCT07364383
Probiotics for Women
A study testing Lab4 + Lactobacillus gasseri and Lactobacillus crispatus in people with Probiotic and Microbiome, run by Cultech Ltd at 1 site in Bulgaria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Probiotic, Microbiome, Wellbeing
- What is being tested?
- Lab4 + Lactobacillus gasseri and Lactobacillus crispatus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBulgaria
- Study dates
- 22 Jan 2026to 20 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Probiotic, Microbiome, Wellbeing
- Being tested
- Lab4 + Lactobacillus gasseri and Lactobacillus crispatus, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lab4 + Lactobacillus gasseri and Lactobacillus crispatusDietary supplement
Lactobacillus acidophilus CUL-60, Lactobacillus acidophilus CUL-21, Lactobacillus gasseri CUL-09, Lactobacillus crispatus CUL40, 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
PlaceboOther
MCC alone
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Lab4 Multi-strain Probiotic + Lactobacillus gasseri and Lactobacillus crispatus (comprising Lactobacilli and bifidobacteria species) with Vitamin A and Vitamin D Receives: Dietary Supplement: Lab4 + Lactobacillus gasseri and Lactobacillus crispatus |
| Placebo | Placebo comparator | Matching placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in wellbeing through the use of wellbeing diaries
Changes in wellbeing and in the composition of the microbiome
Measured: From date of randomization until the end of the intervention period (20 days)
Changes in microbiome composition through shotgun Metagenomics
Measured: From date of randomization until the end of the intervention period (20 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start22 Jan 2026
- Primary completion17 Mar 2026
- Study completion20 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProbioticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cultech Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07364383
- Sponsor's protocol ID
- MMS
- Status last verified
- Aug 2026
- First submitted
- 6 Jan 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiome and Wellbeing Modulation in Women: An Exploratory Probiotic Study
- ClinicalTrials.gov ID
- NCT07364383
- Acronym / sponsor ID
- MMS
- Conditions
- Probiotic, Microbiome, Wellbeing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cultech LtdIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2026 (actual)
- Primary completion
- 17 Mar 2026 (actual)
- Study completion
- 20 Apr 2026 (actual)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Dietary Supplement: Lab4 + Lactobacillus gasseri and Lactobacillus crispatusLab4 Multi-strain Probiotic + Lactobacillus gasseri and Lactobacillus crispatus (comprising Lactobacilli and bifidobacteria species) with Vitamin A and Vitamin D |
| Placebo | Placebo comparator | Other: PlaceboMatching placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lab4 + Lactobacillus gasseri and Lactobacillus crispatusLactobacillus acidophilus CUL-60, Lactobacillus acidophilus CUL-21, Lactobacillus gasseri CUL-09, Lactobacillus crispatus CUL40, 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 | Dietary supplement | Active |
| PlaceboMCC alone | Other | Placebo |
Primary outcome
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
Changes in microbiome composition through shotgun Metagenomics
Time frame: From date of randomization until the end of the intervention period (20 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: Yes
Related trials for Probiotic
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
RecruitingPhase 1
The Gut - PRO Study
Alzheimer Disease
Not yet recruitingPhase 1
A Safety Trial to Evaluate an Orally Ingested Yeast Modified to Express a Tetra-specific Anti-toxin for Clostridioides Difficile
Clostridium Difficile Infection
RecruitingPhase 2
CASCADE 2002: PROTECT Study, "PRObiotics to TrEat Anal preCancer Trial
HSIL, High Grade Squamous Intraepithelial Lesion, HPV-Related Squamous Cell Carcinoma
RecruitingPhase 2
Phase II Clinical Study of Probiotic LR607 in Patients With Non-Small Cell Lung Cancer
NSCLC Diagnosed by Histology or Cytology, A Multidisciplinary Team Assessment Determined That the Patient Was a Suitable Candidate for Radical Surgical Resection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lab4 + Lactobacillus gasseri and Lactobacillus crispatus in people with Probiotic and Microbiome, run by Cultech Ltd at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in wellbeing through the use of wellbeing diaries (time frame: From date of randomization until the end of the intervention period (20 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.