Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000404325
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
20/03/2026
Date registered
Help: Date registered
1/04/2026
Date last updated
Help: Date last updated
17/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
1/04/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of LactoSpore in perimenopausal women.
Scientific title
A randomised, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of LactoSpore (Heyndrickxia coagulans MTCC 5856) in perimenopausal women.
Additional trial identifiers [1] 316823 0
None
Universal Trial Number (UTN)
U1111-1337-7106
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Vasomotor symptoms 341175 0
Anxiety 341176 0
Depressive symptoms 341177 0
Sleep disturbance 341178 0
Fatigue 341179 0
Perimenopausal symptoms 343635 0
Condition category
Condition code
Reproductive Health and Childbirth 337265 337265 0 0
Menstruation and menopause
Mental Health 337266 337266 0 0
Other mental health disorders
Alternative and Complementary Medicine 337268 337268 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Heyndrickxia coagulans MTCC 5856 (LactoSpore) (1 capsule taken orally, once daily, in the morning, approximately 30 minutes before breakfast, delivering 2 billion spores a day for 12 weeks). Adherence to capsule intake will be measured by a count of capsules returned at week 12.
Intervention code [1] 333509 0
Treatment: Other
Description of the comparator or control
A matching placebo (containing maltodextrin) in terms of taste and appearance, and containing all ingredients except the active ingredient Heyndrickxia coagulans MTCC 5856 (LactoSpore).
Control group
Placebo

Outcomes
Primary outcome [1] 346922 0
Menopausal symptoms
Timepoint [1] 346922 0
Day 0 (the day before commencement of intervention), week 4, 8, and 12 post-intervention commencement (primary endpoint)
Secondary outcome [1] 459183 0
Vasomotor symptoms
Timepoint [1] 459183 0
Day 0 (the day before commencement of intervention), week 4, 8, and 12 post-intervention commencement
Secondary outcome [2] 459184 0
Psychosocial symptoms
Timepoint [2] 459184 0
Day 0 (the day before commencement of intervention), week 4, 8, and 12 post-intervention commencement
Secondary outcome [3] 459185 0
Physical symptoms
Timepoint [3] 459185 0
Day 0 (the day before commencement of intervention), week 4, 8, and 12 post-intervention commencement
Secondary outcome [4] 459186 0
Sexual symptoms
Timepoint [4] 459186 0
Day 0 (the day before commencement of intervention), week 4, 8, and 12 post-intervention commencement
Secondary outcome [5] 459194 0
Oestradiol
Timepoint [5] 459194 0
Day 0 (the day before commencement of intervention) and week 12 post-intervention commencement
Secondary outcome [6] 459195 0
Progesterone
Timepoint [6] 459195 0
Day 0 (the day before commencement of intervention) and week 12 post-intervention commencement
Secondary outcome [7] 459196 0
Testosterone
Timepoint [7] 459196 0
Day 0 (the day before commencement of intervention) and week 12 post-intervention commencement
Secondary outcome [8] 459197 0
Global impression of change in perimenopausal symptoms
Timepoint [8] 459197 0
Week 12 post-intervention commencement
Secondary outcome [9] 459284 0
Depressive symptoms
Timepoint [9] 459284 0
Day 0 (the day before commencement of intervention), week 4, 8, and 12 post-intervention commencement
Secondary outcome [10] 459285 0
Anxiety symptoms
Timepoint [10] 459285 0
Day 0 (the day before commencement of intervention), week 4, 8, and 12 post-intervention commencement
Secondary outcome [11] 459286 0
Sleep disturbance
Timepoint [11] 459286 0
Day 0 (the day before commencement of intervention), week 4, 8, and 12 post-intervention commencement
Secondary outcome [12] 459287 0
Fatigue
Timepoint [12] 459287 0
Day 0 (the day before commencement of intervention), week 4, 8, and 12 post-intervention commencement
Secondary outcome [13] 459289 0
Follicle-stimulating hormone
Timepoint [13] 459289 0
Day 0 (the day before commencement of intervention) and week 12 post-intervention commencement
Secondary outcome [14] 459290 0
Luteinising hormone
Timepoint [14] 459290 0
Day 0 (the day before commencement of intervention) and week 12 post-intervention commencement
Secondary outcome [15] 459291 0
Thyroid-stimulating hormone
Timepoint [15] 459291 0
Day 0 (the day before commencement of intervention) and week 12 post-intervention commencement
Secondary outcome [16] 459292 0
Fasting blood glucose
Timepoint [16] 459292 0
Day 0 (the day before commencement of intervention) and week 12 post-intervention commencement
Secondary outcome [17] 459294 0
Glycated haemoglobin
Timepoint [17] 459294 0
Day 0 (the day before commencement of intervention) and week 12 post-intervention commencement
Secondary outcome [18] 459296 0
High-sensitivity C-reactive protein
Timepoint [18] 459296 0
Day 0 (the day before commencement of intervention) and week 12 post-intervention commencement
Secondary outcome [19] 459297 0
Cholesterol
Timepoint [19] 459297 0
Day 0 (the day before commencement of intervention) and week 12 post-intervention commencement
Secondary outcome [20] 459301 0
Triglycerides
Timepoint [20] 459301 0
Day 0 (the day before commencement of intervention) and week 12 post-intervention commencement
Secondary outcome [21] 459304 0
Low-density lipoprotein
Timepoint [21] 459304 0
Day 0 (the day before commencement of intervention) and week 12 post-intervention commencement
Secondary outcome [22] 459305 0
High-density lipoprotein
Timepoint [22] 459305 0
Day 0 (the day before commencement of intervention) and week 12 post-intervention commencement
Secondary outcome [23] 459311 0
Renal function profile composite score (safety measure)
Timepoint [23] 459311 0
Day 0 (the day before commencement of intervention) and week 12 post-intervention commencement
Secondary outcome [24] 459312 0
Complete blood count composite score (safety measure)
Timepoint [24] 459312 0
Day 0 (the day before commencement of intervention) and week 12 post-intervention commencement
Secondary outcome [25] 459313 0
Liver function profile composite score (safety measure)
Timepoint [25] 459313 0
Day 0 (the day before commencement of intervention) and week 12 post-intervention commencement

Eligibility
Key inclusion criteria
1. Women aged 40 to 55 years
2. For at least eight weeks, has experienced changes in the menstrual cycle consistent with perimenopause.
3. Is experiencing at least two perimenopause-related symptoms that have been present for at least eight weeks and have interfered with quality of life, rated at least 4 on a 0–10 numerical rating scale during the previous four weeks.
4. Non-smoker
5. BMI between 18 and 35 kg/m2
6. No plan to commence new treatments over the study period.
7. Understand, willing and able to comply with all study procedures.
8. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
Minimum age
40 Years
Maximum age
55 Years
Sex
Females
Healthy volunteers
No
Key exclusion criteria
1. Menopause has been induced through surgery such as bilateral oophorectomy or salpingo-oophorectomy, chemotherapy, radiation, or drugs.
2. Has had a partial or total hysterectomy
3. Use of any treatment for menopausal symptoms
4. Suffering from a recently diagnosed or unmanaged medical condition, including but not limited to diabetes, hypertension, cardiovascular disease, gastrointestinal disease, biliary disease, autoimmune disease, endocrine disease, or chronic/acute pain condition.
5. Has a history of cancer (any type)
6. History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs (i.e., Crohn's disease, short bowel, acute or chronic pancreatitis or pancreatic insufficiency).
7. Has a neurological disease (e.g., Parkinson’s disease, Alzheimer’s disease), experienced a significant neurological injury (e.g., intracranial haemorrhage, or head injury), or currently has a major psychiatric condition that significantly affects daily function.
8. History of any clinically significant disease or disorder which, in the opinion of the investigator, may place the participant at risk because of participation in the study, or adversely affect the participant’s ability to participate in the study.
9. Experienced any acute infection in the month before study commencement
10. Regular consumption of probiotic-containing supplements or in the last 3 months, has taken probiotics
11. In the last 3 months, the commencement of, or change in, pharmaceutical medications (including antibiotics), likely to affect treatment outcomes or an expectation to change during the study duration
12. In the last 3 months, the commencement of, or change in, nutritional or herbal supplements likely to affect treatment outcomes or an expectation to change during the study duration
13. Has a known sensitivity, intolerance, or allergy to any of the investigational ingredients or their excipients
14. Planned major lifestyle or dietary change during the study period.
15. Alcohol intake greater than 14 standard drinks per week
16. Current or 12-month history of illicit drug abuse
17. Pregnant women, women who are breastfeeding, or women who intend to become pregnant during the study period.
18. In the last year, has had a significant surgery that affects general health or daily function, or a planned surgery during the study period.
19. Participation in any other clinical trial in the last month

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered opaque cartons
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/04/2026
Actual
18/06/2026
Date of last participant enrolment
Anticipated
21/12/2026
Actual
Date of last data collection
Anticipated
15/03/2027
Actual
Sample size
Target
90
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 321416 0
Commercial sector/Industry
Name [1] 321416 0
Sabinsa Corporation
Country [1] 321416 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Clinical Research Australia
Address
Country
Australia
Secondary sponsor category [1] 324160 0
Commercial sector/Industry
Name [1] 324160 0
Sabinsa Corporation
Address [1] 324160 0
Country [1] 324160 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319955 0
National Institute of Integrative Medicine Human Research Ethics Committee
Ethics committee address [1] 319955 0
Ethics committee country [1] 319955 0
Australia
Date submitted for ethics approval [1] 319955 0
12/01/2026
Approval date [1] 319955 0
03/03/2026
Ethics approval number [1] 319955 0
0164E_2026

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 148950 0
Dr Adrian Lopresti
Address 148950 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 148950 0
Australia
Phone 148950 0
+61 8 94487376
Fax 148950 0
Email 148950 0
[email protected]
Contact person for public queries
Name 148951 0
Adrian Lopresti
Address 148951 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 148951 0
Australia
Phone 148951 0
+61 8 94487376
Fax 148951 0
Email 148951 0
[email protected]
Contact person for scientific queries
Name 148952 0
Adrian Lopresti
Address 148952 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 148952 0
Australia
Phone 148952 0
+61 8 94487376
Fax 148952 0
Email 148952 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Case-by-case basis at the discretion of Primary Sponsor

Conditions for requesting access:
• No requirements
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of: 5 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Access subject to approvals by Principal Investigator ([email protected])

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.