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New treatment option for Menopause
Official title Menopausal Symptoms Probiotic Study
ClinicalTrials.gov ID: NCT06446869
What this study is testing
- What it's testing
- 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
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 42 to 60, women only
You may be able to join if
- 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
You likely can't join if
- 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...
- Use of any food supplement containing probiotics or postbiotics or regular consumption (\>3 days/week) of foods containing probiotics (including...
- 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...
See the full eligibility criteria
Who can join
- 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.
What rules you out
- 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...
- 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...
- 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 \ 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Glasgow, Glasgow, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 42 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Glasgow, Glasgow, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.