Menopausal Symptoms Probiotic Study

Menopause Clinical Trial

Official title:

Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of the Combination of Levilactobacillus Brevis KABP-052, Lactiplantibacillus Plantarum KABP-051 and Pediococcus Acidilactici KABP-021 on Menopausal Symptoms and Quality of Life in Peri- and Post-menopausal Women

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06446869
• Other study ID #: KNK-DONACARE
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 10, 2024
• Est. completion date: February 10, 2025

Study information

• Verified date: May 2024
• Source: Community Pharmacology Services Ltd
• Contact: Karen Hopkins, MBChB
• Phone: 0141 946 7888
• Email: karen.hopkins[@]futuremeds.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: February 10, 2025
• Est. primary completion date: November 25, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 42 Years to 60 Years

Eligibility

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

• 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

• Initiated for new diagnosis or changed dose of UK-approved therapeutic medication or nutraceuticals for a medical condition that can affect study outcomes according to the Investigator's judgement (i.e., statins, anti-hypertensives, etc.) within 90 days prior to study entry

• Diagnosis of primary or secondary immunodeficiency including acquired immunodeficiency syndrome, immunodeficiency, or active oncologic disease

• Known or suspected alcohol or drug abuse

• Any other surgical or medical condition, which in the opinion of the Investigator, may place the participant at higher risk from her participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the study

• Currently participating in another study or having participated in one within 3 months prior to the start of the study

• The participant is pregnant, planning a pregnancy, or breastfeeding

Related Conditions & MeSH terms

• Menopause

Intervention

Dietary Supplement:
• Gyntima Menopause
Combination of Levilactobacillus brevis KABP-052, Lactiplantibacillus plantarum KABP-051 and Pediococcus acidilactici KABP-021

Other:
• Placebo
Placebo comparator

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Community Pharmacology Services Ltd	Kaneka Americas Holding Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	120 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)-1ß, 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
Secondary	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
Secondary	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
Secondary	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
Secondary	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