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| Name | Class |
|---|---|
| Kaneka Americas Holding Inc. | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gyntima Menopause | Experimental | Study treatment |
|
| Placebo | Placebo Comparator | Placebo comparator arm |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gyntima Menopause | Dietary Supplement | Combination of Levilactobacillus brevis KABP-052, Lactiplantibacillus plantarum KABP-051 and Pediococcus acidilactici KABP-021 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristen Laing, MBChB | Contact | 0141 946 7888 | kristen.laing@futuremeds.com | |
| David Cogan | Contact | 0141 946 7888 | david.cogan@futuremeds.com |
| Name | Affiliation | Role |
|---|---|---|
| Kristen Laing, MBChB | Community Pharmacology Services Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FutureMeds Glasgow | Recruiting | Glasgow | Glasgow | G20 7BE | United Kingdom |
No data will be shared
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| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Study treatment vs Placebo
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Double-Blind
| Placebo | Other | Placebo comparator |
|
| 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. | 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. | 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) | 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. | 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. | 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. | 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 | 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) | 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 | 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" | 120 days |