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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
140
Combination of Levilactobacillus brevis KABP-052, Lactiplantibacillus plantarum KABP-051 and Pediococcus acidilactici KABP-021
Placebo comparator
FutureMeds Glasgow
Glasgow, Glasgow, United Kingdom
RECRUITINGAssess 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
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
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
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
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)
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Time frame: 120 days
Impact on Depression, Anxiety and Stress
To assess the impact of the investigational product on Depress, Anxiety and Stress Scale-21 (DASS-21) This scale form is a short form of the 42 item self reported questionnaire measuring depression, anxiety and stress. The 21 items on this questionnaire comprise a set of 3 self-reported scales designed to assess DASS. The 7 elements on the scales are graded on a Likert scale from 0 to 3.
Time frame: 120 days
Impact on levels of reproductive hormones
To assess the impact of the investigational product on levels of relevant reproductive hormones during peri- and post-menopause Efficacy laboratory tests are to be performed for all participants as indicated in the protocol's SoA. For Hormones - Oestrone, Oestradiol, FSH and progesterone.
Time frame: 120 days
Impact on serum inflammation markers
To assess the impact of the investigational product on serum inflammation markers Efficacy laboratory tests are to be performed for all participants, as indicated in the protocol's SoA. For Biomarkers - Interleukin (IL)-1β, IL-2, IL-4, IL-6, IL-8, tumour necrosis factor (TNF) and interferon). Note: Analysis of inflammation biomarkers will only be performed at the Sponsor's discretion after the results of hot flashes and QoL become available.
Time frame: 120 days
Impact on gut microbiota composition
To assess the impact of the investigational product on gut microbiota composition The determination of the composition of the faecal microbiota will be carried out through a study of the V3-V4 hypervariable regions of the bacterial ribosomal 16S rRNA gene. Next, the libraries will be set up, and ultrasequencing, bioinformatics and statistical analysis will be carried out. The analysis will be performed in a specialised company called Microomics Systems S.L. located in Barcelona, Spain. Stool samples will be collected by study participants
Time frame: 120 days
Impact on digestive tolerance
To assess the impact of the investigational product on digestive tolerance. This will be assessedbased on documented gastrointestinal symptoms on the Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: 120 days
Safety of the IP
To assess the safety of the investigational product Safety evaluation based on AE registry, Blood cell count and basic blood biochemistry
Time frame: 120 days
Satisfaction of Use
To assess the satisfaction with the use of the investigational product Product satisfaction will be evaluated by using an ordinal 5-point Likert scale, where study participants will have to rate the degree to which they agree or disagree with the statement: "Please indicate the degree of satisfaction or dissatisfaction with the way the study product has relieved your symptoms associated to menopause"
Time frame: 120 days