Menopausal Symptoms Probiotic Study
Launched by COMMUNITY PHARMACOLOGY SERVICES LTD · May 31, 2024
Trial Information
Current as of February 18, 2025
Not yet recruiting
Keywords
ClinConnect Summary
No description provided
Gender
FEMALE
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
Trial Officials
Karen Hopkins, MBChB
Principal Investigator
Community Pharmacology Services Ltd
About Community Pharmacology Services Ltd
Community Pharmacology Services Ltd. is a leading clinical trial sponsor dedicated to advancing pharmaceutical research and development through innovative community-based approaches. With a focus on enhancing patient access to clinical trials, the organization collaborates with healthcare providers and stakeholders to ensure robust study designs and effective participant recruitment. Committed to upholding the highest standards of regulatory compliance and ethical conduct, Community Pharmacology Services Ltd. leverages its expertise in pharmacology to facilitate the exploration of new therapies, ultimately aiming to improve health outcomes in diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0