Clinical trial NCT06446869: Menopausal Symptoms Probiotic Study
Official title: Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of the Combination of Levilactobacillus Brevis KABP-052, Lactiplantibacillus Plantarum KABP-051 and Pediococcus Acidilactici KABP-021 on Menopausal Symptoms and Quality of Life in Peri- and Post-menopausal Women
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Menopause
Keywords: menopause
menopausal symptoms
hot flashes
night sweats
menopause treatment
Lead sponsor: Community Pharmacology Services Ltd
Sponsor class: OTHER
Collaborators: name: Kaneka Americas Holding Inc.
First posted: 2024-06-06
Enrollment: 140
Sex: FEMALE
Minimum age (years): 42
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study treatment vs Placebo
Primary purpose: PREVENTION

Brief summary: In this study, we want to investigate if the active product consisting of a probiotic blend can potentiate the recirculation of active oestrogens into the bloodstream and help to mitigate menopause symptoms, which are closely related to oestrogens levels


Eligibility criteria: Inclusion Criteria:

* Perimenopausal or post-menopausal women with spontaneous menopause and amenorrhoea for less than 2 years
* Self reported menopausal symptoms (5 or more hot flashes/night sweats per day or 35 or more per week recorded daily for 14 consecutive days)
* BMI between 18.5 and 34.9 kg/m2
* Menopause rating score II (MRS-II) total score of 9 or more at baseline visit
* Willing to sign Informed Consent Form
* Willing to not make relevant changes to their current dietary or lifestyle habits during study
* Able to follow study procedures
* If perimenopausal, agrees to use an accepted method of contraception for duration of study.

Exclusion Criteria:

* History of hysterectomy, oophorectomy, endometrial hyperplasia, uterine or endometrial cancer, breast cancer, or cancers associated with sex hormones
* Use of hormonal replacement therapy, hormone analogues, or oral contraceptives within 3 months prior to the start of the study
* Intake of herbal or food supplements with known effects on menopause symptoms within 1 month prior to the start of the study. Examples of prohibited substances are black cohosh, melatonin, ginseng, chasteberry, phytoestrogens (e.g., hop \[Humulus lupulus L.\], soy isoflavones, red clover) within 1 month prior to the start of the study
* Use of any food supplement containing probiotics or postbiotics or regular consumption (\>3 days/week) of foods containing probiotics (including yogurt with added probiotics or bifidus effect) within 1 month prior to the start of the study
* Use of oral (\>3 days) or parenteral antibiotics within 1 month prior to the start of the study
* Participants with a new diagnosis of mental health disorder in the last 12 months or with an unstable or uncontrolled mental health disorder in the opinion of the Investigator
* Diagnosis of type 1 or uncontrolled type 2 diabetes mellitus
* Diagnosis of chronic gastrointestinal disease, such as inflammatory bowel disease (Crohn's disease or ulcerative colitis), pancreatitis, or short bowel syndrome
* History of thyroid disorders (hypothyroidism or hyperthyroidism) which are untreated or unstable
* History of gastrointestinal surgery 6 months prior to the start of the study, with the exception of appendicectomy
* Regular intake (\>3 days/week) of medication that affects microbiota or bowel movements, namely laxatives like polyethylene glycol or stimulant laxatives (bisacodyl, sennosides, sodium pyrosulfate)
* History of coronary disease, myocardial infarction, unstable angina, or previous coronary angioplasty
* History of venous thromboembolism (VTE) or known to be high risk for VTE due to inherited or acquired thrombophilia (such as factor V Leiden, antiphospholipid syndrome)
* History of stroke or transient ischaemic attack
* History of severe renal dysfunction as defined by an estimated glomerular filtration rate \<30 mL/minute or severe liver dysfunction defined as established cirrhosis or active liver disease with alanine aminotransferase (ALT) \>3 × upper limit of normal at baseline
* Initiated for new diagnosis or changed dose of UK-approved therapeutic medication or nutraceuticals for a medical condition that can affect study outcomes according to the Investigator's judgement (i.e., statins, anti-hypertensives, etc.) within 90 days prior to study entry
* Diagnosis of primary or secondary immunodeficiency including acquired immunodeficiency syndrome, immunodeficiency, or active oncologic disease
* Known or suspected alcohol or drug abuse
* Any other surgical or medical condition, which in the opinion of the Investigator, may place the participant at higher risk from her participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the study
* Currently participating in another study or having participated in one within 3 months prior to the start of the study
* The participant is pregnant, planning a pregnancy, or breastfeeding

Primary outcomes:
measure: Assess Impact
timeFrame: 120 days
Secondary outcomes:
measure: Impact on Severity of Symptoms
timeFrame: 120 days
measure: Impact on number of Hot Flashes / Night Sweats
timeFrame: 120 days
measure: Impact on Intensity of Hot Flashes / Night Sweats
timeFrame: 120 days
measure: Impact on QoL
timeFrame: 120 days
measure: Impact on Depression, Anxiety and Stress
timeFrame: 120 days
measure: Impact on levels of reproductive hormones
timeFrame: 120 days
measure: Impact on serum inflammation markers
timeFrame: 120 days
measure: Impact on gut microbiota composition
timeFrame: 120 days
measure: Impact on digestive tolerance
timeFrame: 120 days
measure: Safety of the IP
timeFrame: 120 days
measure: Satisfaction of Use
timeFrame: 120 days
Other outcomes:
Locations:
Study officials:
affiliation: Community Pharmacology Services Ltd
name: Karen Hopkins, MBChB
role: PRINCIPAL_INVESTIGATOR
References: