Actively Recruiting
Menopausal Symptoms Probiotic Study
Led by Community Pharmacology Services Ltd · Updated on 2026-01-26
140
Participants Needed
1
Research Sites
110 weeks
Total Duration
On this page
Sponsors
C
Community Pharmacology Services Ltd
Lead Sponsor
K
Kaneka Americas Holding Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Menopausal Symptoms Probiotic Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women who are perimenopausal or postmenopausal with spontaneous menopause and have not had menstruation for less than 2 years
- Experience five or more hot flashes or night sweats per day, or 35 or more per week documented daily for 14 days
- Body mass index (BMI) between 18.5 and 34.9 kg/m2
- Menopause rating score II (MRS-II) total score of 9 or higher at the start of the study
- Willing to sign the informed consent form
- Agree not to make significant changes to diet or lifestyle during the study
- Able to follow study procedures
- If perimenopausal, agrees to use an accepted method of contraception during the study
You will not qualify if you...
- History of hysterectomy, oophorectomy, endometrial hyperplasia, uterine or endometrial cancer, breast cancer, or other sex hormone-related cancers
- Use of hormonal replacement therapy, hormone analogues, or oral contraceptives within 3 months before the study
- Use of herbal or food supplements affecting menopause symptoms within 1 month before the study, including black cohosh, melatonin, ginseng, chasteberry, or phytoestrogens like hop, soy isoflavones, or red clover
- Use of probiotics, postbiotics, or probiotic-containing foods regularly within 1 month before the study
- Use of oral or injectable antibiotics for more than 3 days within 1 month before the study
- New or unstable mental health disorder diagnosed within the last 12 months
- Diagnosis of type 1 diabetes or uncontrolled type 2 diabetes
- Diagnosis of chronic gastrointestinal diseases such as Crohn's disease, ulcerative colitis, pancreatitis, or short bowel syndrome
- Untreated or unstable thyroid disorders
- Gastrointestinal surgery within 6 months before the study, except appendectomy
- Regular use of medications affecting microbiota or bowel movements, such as laxatives
- History of coronary artery disease, heart attack, unstable angina, or coronary angioplasty
- History or high risk of venous thromboembolism (VTE)
- History of stroke or transient ischemic attack
- Severe kidney or liver dysfunction as defined by specific lab criteria
- Recent change or start of medications that may affect study outcomes within 90 days before study entry
- Diagnosis of immunodeficiency or active cancer
- Known or suspected alcohol or drug abuse
- Other medical or surgical conditions that increase risk or prevent study participation
- Current participation in another study or participation within 3 months prior
- Pregnancy, planning pregnancy, or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
FutureMeds Glasgow
Glasgow, Glasgow, United Kingdom, G20 7BE
Actively Recruiting
Research Team
K
Kristen Laing, MBChB
CONTACT
D
David Cogan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here