Menopausal Symptoms Probiotic Study

What this trial studies

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 in scope

• Menopause

Interventions

• Gyntima Menopause (Dietary Supplement) — Combination of Levilactobacillus brevis KABP-052, Lactiplantibacillus plantarum KABP-051 and Pediococcus acidilactici KABP-021
• Placebo (Other) — Placebo comparator

Who can join

Women only · Ages 42 Years to 60 Years

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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2024-09-10
• Primary completion: 2026-07-25
• Last update posted: 2026-01-26
• First posted: 2024-06-06

Sponsor & contact

Lead sponsor: Community Pharmacology Services Ltd (Other)

Collaborators: Kaneka Americas Holding Inc.

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Assess Impact (120 days)
  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…

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.