None listed
Conditions
Brief summary
In this randomised, double-blind, placebo-controlled study, 90 perimenopausal women aged 40 to 55 years with persistent perimenopausal symptoms that negatively affect their quality of life will be randomly assigned to receive LactoSpore (Heyndrickxia coagulans MTCC 5856) or a matching placebo for 12 weeks. The primary outcome will be a change in overall menopause-specific quality of life, assessed using the MENQOL-I total score. Secondary outcomes will include MENQOL-I vasomotor, psychosocial, physical and sexual domain scores, together with measures of depression, anxiety, sleep disturbance, fatigue and global improvement in perimenopausal symptoms. Selected hormonal, metabolic, inflammatory and lipid markers will also be evaluated, together with safety and tolerability.
Interventions
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.
Sponsors
Clinical Research Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Women aged 40 to 55 years 2. For at least 3 months, has experienced changes in the menstrual cycle (e.g., changes in bleeding days, heaviness of bleeding, or days between menses) 3. Experiencing hot flushes and/or night sweats equal to or greater than 3 times daily 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.
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
Outcome results
None listed