Menopausal Symptoms Probiotic Study

NCT06446869 | Recruiting

• 1 other identifier: KNK-DONACARE
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Conditions

Menopause

Keywords

menopause; menopausal symptoms; hot flashes; night sweats; menopause treatment

Outcome Measures

Primary Outcomes (1)

• Assess Impact

  To assess the impact of the investigational product on the symptoms and quality of life (QoL) in menopausal women as assessed by Menopause Rating Score II (MRS-II) Each of the 11 symptoms contained in the scale can get 0 (no complaints) or up to 4 scoring points (severe symptoms) depending on the severity of the complaints perceived by the women completing the scale (an appropriate box is to be ticked). The score increases point by point with increasing severity of subjectively perceived symptoms in each of the 11 items.

  120 days

Secondary Outcomes (11)

• Impact on Severity of Symptoms

  120 days

• Impact on number of Hot Flashes / Night Sweats

  120 days

• Impact on Intensity of Hot Flashes / Night Sweats

  120 days

• Impact on QoL

  120 days

• Impact on Depression, Anxiety and Stress

  120 days

Study Arms (2)

Gyntima Menopause

EXPERIMENTAL

Study treatment

Dietary Supplement: Gyntima Menopause

Placebo

PLACEBO COMPARATOR

Placebo comparator arm

Other: Placebo

Interventions

Gyntima Menopause DIETARY_SUPPLEMENT

Combination of Levilactobacillus brevis KABP-052, Lactiplantibacillus plantarum KABP-051 and Pediococcus acidilactici KABP-021

Gyntima Menopause

Placebo OTHER

Placebo comparator

Placebo

Eligibility Criteria

• Age: 42 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify 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
• 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.

You may not qualify 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 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

Sponsors & Collaborators

• Community Pharmacology Services Ltd: lead
• Kaneka Americas Holding Inc.: collaborator

Study Sites (1)

FutureMeds Glasgow

Glasgow, Glasgow, G20 7BE, United Kingdom

RECRUITING

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kristen Laing, MBChB

  Community Pharmacology Services Ltd

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristen Laing, MBChB

CONTACT

0141 946 7888; kristen.laing@futuremeds.com

David Cogan

CONTACT

0141 946 7888; david.cogan@futuremeds.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Double-Blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study treatment vs Placebo

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: June 6, 2024
• Study Start: September 10, 2024
• Primary Completion (Estimated): July 25, 2026
• Study Completion (Estimated): October 25, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)