This study is only available for people able to travel to our office in Duncraig, WA 6023

Preliminary research suggests that probiotics may help reduce menopausal symptoms. Therefore, the aim of this study is to investigate the effects of a probiotic called LactoSpore® on hot flushes, night sweats and other menopausal-related symptoms (e.g., changes in mood, sleep, energy, libido, cognition, weight, digestion, or joint pain) in perimenopausal women experiencing, on average, at least 3 hot flushes/ night sweats a day. Furthermore, to help understand how LactoSpore® works, changes in blood markers that may influence menopausal symptoms will be examined over time.

If you are a generally healthy female aged 40-55 years, experiencing perimenopause and, on average, having at least 3 hot flushes/night sweats per day, we invite you to participate in this randomised, controlled study. 

PLEASE NOTE: Travel to our office in Duncraig is required on TWO occasions

Eligible participants will be RANDOMLY allocated into ONE of TWO treatment conditions: 

1. Daily intake of capsules containing a probiotic, or
2. Daily intake of placebo (fake) capsules 

This 12-week study consists of the following:

1. Visit our office (located in Duncraig, Western Australia) on 2 occasions (days 0 and week 12). During these in-person visits (approximately 60 minutes), we will measure your weight, height, and blood pressure. You will also need to complete several questionnaires regarding your menopausal symptoms, mood, sleep, and fatigue.
2. Visit a Western Diagnostics Pathology clinic to have a blood sample collected from you at the beginning and end of the study.
3. Take 1 capsule once daily for 12 weeks.
4. Keep a 7-day record of your hot flushes/night sweats at weeks 0 (baseline), 4, 8, and 12. This will be done on your phone and will take less than 1 minute daily.
5. Complete online questionnaires in weeks 4 and 8, which will take around 5 to 10 minutes. 

You can download the full STUDY INFORMATION SHEET by clicking the button on this webpage

To compensate you for the time and travel involved in this study, you will receive a $30 gift voucher on your first visit and a $140 gift voucher on your second visit. Participants in the placebo group will also receive a complimentary 12-week supply of Probiotic capsules upon completion of this study.

To be INCLUDED in the study, the following inclusion criteria must be met:

1. You are a female aged 40 to 55 years
2. For at least 3 months, you have experienced changes in your menstrual cycle (e.g., changes in bleeding days, heaviness of bleeding, or days between menses)
3. You are experiencing, on average, at least 3 hot flushes and/or night sweats a day
4. You have been a non-smoker for at least 12 months
5. You have a body mass index between 18 and 35 kg/m2
6. You have no plan to commence new treatments over the study period.
7. You understand, are willing and able to comply with all study procedures.
8. You are willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.

If any of the exclusion criteria below are met, the applicant will not be suitable for participation in this study:

1. Your menopause has been induced through surgery such as bilateral oophorectomy or salpingo-oophorectomy, chemotherapy, radiation, or drugs.
2. You have had a partial or total hysterectomy
3. You are currently receiving any treatment for your menopausal symptoms
4. You are 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. You have a history of cancer (any type)
6. You have a 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. You have a neurological disease (e.g., Parkinson’s disease, Alzheimer’s disease), have experienced a significant neurological injury (e.g., intracranial haemorrhage, or head injury), or currently have a major psychiatric condition that significantly affects daily function.
8. You have experienced an acute infection in the month before study commencement
9. You regularly take probiotic-containing supplements, or in the last 3 months, have taken probiotics
10. In the last 3 months, you have commenced or changed pharmaceutical medications (including antibiotics), which are likely to affect treatment outcomes, or you expect to change medications during the study duration
11. In the last 3 months, you have commenced or changed nutritional or herbal supplements, which are likely to affect treatment outcomes, or you expect to change them during the study duration
12. You have a sensitivity, intolerance, or allergy to probiotics or other excipients in the capsules
13. You plan on making major lifestyle or dietary change during the study period.
14. Your alcohol intake is greater than 14 standard drinks per week
15. You have a current or 12-month history of regular illicit drug use
16. You are pregnant, breastfeeding, or intend to become pregnant during the study period.
17. In the last year, you have had a significant surgery that affects your general health or daily function, or you have a planned surgery during the study period.
18. You have participated in any other clinical trial in the last month.

This study has been approved by the National Institute of Integrative Medicine (NIIM) Ethics Committee (Reference number: 0164E_2026)

If you are interested in participating in this study, please click on the button "Check if you are eligible located on this webpage. This questionnaire will take approximately 5 to 10 minutes to complete and helps us assess your eligibility to participate in this study.

Please Note: All answers are confidential and will only be seen by study investigators. If you are not eligible to participate in this study, your records will be deleted immediately

If you would like to speak to a researcher to get more information about this study, you can call us on 08 9448 7376