MenopauseNCT06446869
Menopausal Symptoms Probiotic Study
A study testing Gyntima Menopause in people with Menopause, run by Community Pharmacology Services Ltd at 1 site in United Kingdom.
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 Read more about this study
- Who is it for?
- Ages 42 to 60 years, women only
- Conditions the study is for
- Menopause
- What is being tested?
- Gyntima Menopause
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Sep 2024to 25 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 42 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
FutureMeds Glasgow
Glasgow, Glasgow, G20 7BE
Karen Hopkins, MBChB, 0141 946 7888, karen.hopkins@futuremeds.com
About this study
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
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
- Menopause
- Being tested
- Gyntima Menopause, Placebo
- Keywords
- menopause, menopausal symptoms, hot flashes, night sweats, menopause treatment
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gyntima MenopauseDietary supplement
Combination of Levilactobacillus brevis KABP-052, Lactiplantibacillus plantarum KABP-051 and Pediococcus acidilactici KABP-021
PlaceboOther
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Gyntima Menopause | Experimental | Study treatment Receives: Dietary Supplement: Gyntima Menopause |
| Placebo | Placebo comparator | Placebo comparator arm Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 120 days
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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
Measured: 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"
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start10 Sep 2024
- Primary completion25 Jul 2026 (estimated)
- Study completion25 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study treatment vs Placebo
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Community Pharmacology Services Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Kaneka Americas Holding Inc.
- Responsible party
- Sponsor
- Investigators
- Kristen Laing, MBChB, Principal investigator, Community Pharmacology Services Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446869
- Sponsor's protocol ID
- KNK-DONACARE
- Status last verified
- Jan 2026
- First submitted
- 17 May 2024
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06446869
- Acronym / sponsor ID
- KNK-DONACARE
- Conditions
- Menopause
- Keywords
- menopause, menopausal symptoms, hot flashes, night sweats, menopause treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Community Pharmacology Services LtdUniversity, hospital or other
- Collaborators
- Kaneka Americas Holding Inc.
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 25 Jul 2026 (estimated)
- Study completion
- 25 Oct 2026 (estimated)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Study treatment vs Placebo
| Arm | Type | Receives |
|---|---|---|
| Gyntima Menopause | Experimental | Dietary Supplement: Gyntima MenopauseStudy treatment |
| Placebo | Placebo comparator | Other: PlaceboPlacebo comparator arm |
Who may qualify
- Ages
- 42 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gyntima MenopauseCombination of Levilactobacillus brevis KABP-052, Lactiplantibacillus plantarum KABP-051 and Pediococcus acidilactici KABP-021 | Dietary supplement | Gyntima Menopause |
| PlaceboPlacebo comparator | Other | Placebo |
Primary outcome
Assess Impact
Time frame: 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 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.
11 secondary outcomes
Impact on Severity of Symptoms
Time frame: 120 days
Impact on number of Hot Flashes / Night Sweats
Time frame: 120 days
Impact on Intensity of Hot Flashes / Night Sweats
Time frame: 120 days
Impact on QoL
Time frame: 120 days
Impact on Depression, Anxiety and Stress
Time frame: 120 days
Impact on levels of reproductive hormones
Time frame: 120 days
Impact on serum inflammation markers
Time frame: 120 days
Impact on gut microbiota composition
Time frame: 120 days
Impact on digestive tolerance
Time frame: 120 days
Safety of the IP
Time frame: 120 days
Satisfaction of Use
Time frame: 120 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No. No data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristen Laing, MBChB principal investigator
Community Pharmacology Services Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gyntima Menopause in people with Menopause, run by Community Pharmacology Services Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristen Laing, MBChB (0141 946 7888, kristen.laing@futuremeds.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess Impact (time frame: 120 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.