Health TrialsbyHealthPanel

Menopausal Symptoms Probiotic Study

ConditionMenopause
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age42-60
SponsorCommunity Pharmacology Services Ltd

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Gyntima Menopause

    Dietary supplement

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

  • Placebo

    Other intervention

    Placebo comparator

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Gyntima MenopauseExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
120 days

Secondary outcomes

1

Impact on Severity of Symptoms

To assess the impact of the investigational product on the severity of symptoms as assessed by 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.

Time frame
120 days
2

Impact on number of Hot Flashes / Night Sweats

To assess the impact of the investigational product on the number of hot flashes and night sweats. All study participants will receive a diary where they will report their daily number of hot flashes and night sweats.

Time frame
120 days
3

Impact on Intensity of Hot Flashes / Night Sweats

To assess the impact of the investigational product on the intensity of hot flashes and night sweats All study participants will receive a diary where they will report their daily number of hot flashes and night sweats.

Time frame
120 days
4

Impact on QoL

To assess the impact of the investigational product on menopause-related QoL as assessed by the Greene Climacteric Scale (GCS) questionnaire The Greene Climacteric Scale (GCS) is a standard list of 21 questions which women use to rate how much they are bothered by menopause symptoms such as hot flashes, night sweats, rapid heartbeat, and difficulty sleeping. Each symptom is rated on a 4-point Likert scale from 0 points (not at all) to 3 points (Extremely)

Time frame
120 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Community Pharmacology Services Ltd

Lead sponsor

Kaneka Americas Holding Inc.

Collaborator

Source ClinicalTrials.gov
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