MenopausePhase 2MPSNCT04001088
The Effects of a Novel Probiotic Supplement on Menopausal Symptoms and Bone Health
A Phase 2 study testing Probiotic in people with Menopause, run by Lallemand Health Solutions at 5 sites in United States.
Trial summary
This Phase II study is designed to evaluate the potential effects of a novel probiotic supplement on the severity of global menopause symptoms (e.g., psychological, somatic, urogenital symptoms) and on bone health in postmenopausal women. Read more about this study
- Who is it for?
- Ages 40 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 5 sitesUnited States
- Study dates
- 29 Jul 2019to 23 Apr 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 40 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy post-menopausal woman
- Last menstrual period has occurred at least 12 months prior to screening
- ≥40 to <60 years old
- Vaginal pH ≥ 5
- MRS score ≥ 20
- Willing and able to give written informed consent
- Willing to consume IP or placebo, complete questionnaires, records, and daily diaries associated with the study and to complete all clinical study visits
- Willingness to discontinue consumption of probiotic supplements and food containing added probiotics and/or prebiotics (e.g. yogurts with live, active cultures or supplements) o Note: Screened participants will be eligible to participate after completing a 4-week wash-out period.
Who cannot join
- Milk or soy allergy
- Women with induced menopause through full or partial hysterectomy, chemotherapy or radiation
- Consumption of natural health products used to treat menopausal symptoms such as phytoestrogens, Black Cohosh, dehydroepiandrosterone (DHEA), Dong Quai, vitamin E (>250 IU/day), high consumption of soy food products, unless a 1-month wash-out period has been completed prior to study commencement
- Currently undergoing or have previously undergone HT for treatment of menopausal symptoms, unless a three-month washout has been completed prior to study commencement
- Active vaginal infections/abnormalities (e.g. active urinary tract infection (UTI), genital hemorrhage of unknown origin)
- o Note: Screened participants with infections would be eligible to participate 4 weeks after completing their course of treatment (wash-out period).
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- Use of any vaginal medication, vaginal rinses and/or moisturizers, gels containing xylocaine or other analgesic products to decrease pain during intercourse, 1 week before and during study
- Use of any antibiotic drug within 1 month of screening
- o Note: Screened participants could be eligible to participate after a 2-week wash-out period.
- Participants previously diagnosed with hyperparathyroidism and/or hyperthyroidism
- Participation in other clinical studies in the past 6 months
- History of alcohol or drug abuse in the 12 months prior to screening
- History of cancer (except localized skin cancer without metastases) within five (5) years prior to screening
- History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the potential subject at risk because of participation in the study, or influences the results or the potential subject's ability to participate in the study
- History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs (i.e. Crohn's disease, short bowel, acute or chronic pancreatitis or pancreatic insufficiency)
- History of a surgical procedure for the treatment of obesity (e.g., gastric bypass, gastric banding)
- Currently consuming more than 2 standard alcoholic beverages a day. A standard alcoholic beverage is defined as 12 ounces of beer, five (5) ounces of wine, or 1.5 ounces of liquor
- Difficulty swallowing large pills or large quantities of pills
- Any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the study data
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Albuquerque Clinical Trials
Albuquerque, New Mexico, 87102
NeuroTrials Research Inc.
Atlanta, Georgia, 30342
Viable Research
Henderson, Nevada, 89014
Altus Research
Lake Worth, Florida, 33461
Health Awareness Inc.
Port Saint Lucie, Florida, 34952
About this study
Official title: The Effects of a Novel Probiotic Supplement on Menopausal Symptoms and Bone Health: A Randomized, Double-blind, Parallel, Placebo-Controlled, Multi-Centre Study
This Phase II study is designed to evaluate the potential effects of a novel probiotic supplement on the severity of global menopause symptoms (e.g., psychological, somatic, urogenital symptoms) and on bone health in postmenopausal women.
Read the detailed description
Menopause is a natural phase in which a woman's menstrual cycle permanently cease. During this time, women undergo many biological changes, including a decline of estrogen level or alterations in the vaginal microflora. This can result in the onset of various physiological and psychological menopause-related symptoms which may continue into postmenopausal years.
The present study aims to evaluate the potential effects of a probiotic supplement on global menopause symptoms including psychological, somatic and urogenital symptoms. It is hypothesized that this probiotic, consumed over a 12-week period, will help reduce the symptoms of menopause by modulating the mucosal microflora of the vaginal linings. Additionally, it is hypothesized that the continued consumption of this probiotic combination over a total of 48 weeks will aid in the overall maintenance of bone health and may ameliorate bone density loss.
144 healthy postmenopausal women (≥ 40 to < 60 years old) in the U.S. who are experiencing menopause-related symptoms will be randomized to the study (12-week period), and a subset (72 postmenopausal women) will continue the study for an additional 36 weeks (Bone Health Study).
- Conditions
- Menopause
- Being tested
- Probiotic, Placebo
- Keywords
- Probiotics, Menopausal symptoms, Bone health, Vulvar and vaginal atrophy, Vaginal microflora, Anxiety, Depression, Urinary incontinence, Metabolic syndrome biomarkers, Sleep quality, Gut microflora, Bone resorption markers, Bone formation markers, Bone Mineral Density (BMD), Fracture risk assessment
- Medical subject headings
- Anxiety Disorders, Depression, Urinary Incontinence, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Dosing regimen of one capsule daily for a maximum of 48 weeks.
PlaceboOther
Dosing regimen of one capsule daily for a maximum of 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Probiotics in a capsule. Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Non active ingredients in a capsule. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the global Menopause Rating Scale (MRS) score
Assessed using Menopause Rating Scale (MRS) rating scale. 11 questions on a scale from no complaints (0) to very severe symptoms (4). Subscores are added to create a composite or total score. A higher score indicates a greater severity of menopausal symptoms.
Measured: Measured on weeks -2 (screening visit), 0, 4, 8, 12, and 48.
Secondary outcomes (8)
Change from baseline in individual components of the Menopause Rating Scale (MRS) (psychological, somatic and urogenital symptoms)
Assessed using Menopause Rating Scale (MRS) rating scale. 11 questions on a scale from no complaints (0) to very severe symptoms (4). Subscores are added to create the 3 dimensions scores. A higher score indiactes a greater severity of perceived menopausal symptoms.
Measured: Measured on weeks -2 (screening visit), 0, 4, 8, 12, and 48.
Change from baseline in vaginal pH
Vaginal swabs will be collected for pH testing, using pH strips for screening and to measure evolution of pH throughout first part of the study.
Measured: Measured on weeks -2 (screening visit), 0, and 12.
Change from baseline in vaginal microbiota
Effects of the probiotic intervention on overall microbiota composition will be assessed with a vaginal swab. In addition, recovery of the probiotic strains in the vaginal samples will be assessed.
Measured: Measured on weeks 0 and 12.
Change from baseline in the Patient Health Questionnaire (PHQ-9) total score
Depression measured with the Patient Health Questionnaire (PHQ-9). 10 questions. The first 9 questions are on a scale from not at all bothered by symptoms (0) to bothered by symptoms nearly everyday (3). To arrive at the total score, the individual question scores are added. A score of 5-9 indicates minimal symptoms, a score of 10-14 indicates minor depression, dysthymia, or mild Major Depression, a score of 15-19 indicates moderately sever Major Depression and a score of greater than 20 indicates severe Major Depression.
Measured: Measured on weeks 0, 4, 8, 12, and 48.
Change from baseline in the Pittsburgh Sleep Quality Index (PSQI) global score
Sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI). 9 questions. It consists of seven components including: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction. Each component score ranges from 0 to 3, whereby 3 reflects the negative extreme, for a global score range of 0 to 21. A score of 5 or greater indicates the reporter has poor sleep quality.
Measured: Measured on weeks 0, 4, 8, 12, and 48.
Change from baseline in the Vulvovaginal Symptoms Questionnaire (VSQ) total score.
Vulvar and vaginal atrophy measured with the Vulvovaginal Symptoms Questionnaire (VSQ). 21 yes (1) or no (0) questions in 4 scales: Symptoms, Emotions, Life-impact, Sexual impact. Total score will be the sum of the first 17 questions if non-sexually active or of the 21 questions if sexually active. A higher score indicates a greater severity of vulvar and vaginal atrophy.
Measured: Measured on weeks 0, 4, 8, 12, and 48.
Change in baseline in the Michigan Incontinence Symptom Index (M-ISI) mean score
Urinary incontinence measured with the Michigan Incontinence Symptom Index (M-ISI). 10 questions with different scales all numbered 0-4. The total score is derived from taking the mean of the 10 reported scores. A higher score indicates a higher severity of incontinence.
Measured: Measured on weeks 0, 4, 8, 12, and 48.
Change from baseline in the Generalized Anxiety Disorder-7 (GAD-7) total score
Anxiety measured with the Generalized Anxiety Disorder-7 (GAD-7). 7 questions scaled from not at all sure (0) to nearly every day (3). Total score is derived from the addition of answer to each question. A higher score indicates a higher level of detected anxiety.
Measured: Measured on weeks 0, 4, 8, 12, and 48.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start29 Jul 2019
- Primary completion18 Nov 2020
- Study completion23 Apr 2021
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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lallemand Health Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001088
- Sponsor's protocol ID
- MPS
- Acronym
- MPS
- Status last verified
- Feb 2023
- First submitted
- 25 Jun 2019
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Novel Probiotic Supplement on Menopausal Symptoms and Bone Health: A Randomized, Double-blind, Parallel, Placebo-Controlled, Multi-Centre Study
- ClinicalTrials.gov ID
- NCT04001088
- Acronym / sponsor ID
- MPS / MPS
- Conditions
- Menopause
- Keywords
- Probiotics, Menopausal symptoms, Bone health, Vulvar and vaginal atrophy, Vaginal microflora, Anxiety, Depression, Urinary incontinence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Lallemand Health SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Study start
- 29 Jul 2019 (actual)
- Primary completion
- 18 Nov 2020 (actual)
- Study completion
- 23 Apr 2021 (actual)
- First posted
- 27 Jun 2019 (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.
This Phase II study is designed to evaluate the potential effects of a novel probiotic supplement on the severity of global menopause symptoms (e.g., psychological, somatic, urogenital symptoms) and on bone health in postmenopausal women.
Detailed description
Menopause is a natural phase in which a woman's menstrual cycle permanently cease. During this time, women undergo many biological changes, including a decline of estrogen level or alterations in the vaginal microflora. This can result in the onset of various physiological and psychological menopause-related symptoms which may continue into postmenopausal years.
The present study aims to evaluate the potential effects of a probiotic supplement on global menopause symptoms including psychological, somatic and urogenital symptoms. It is hypothesized that this probiotic, consumed over a 12-week period, will help reduce the symptoms of menopause by modulating the mucosal microflora of the vaginal linings. Additionally, it is hypothesized that the continued consumption of this probiotic combination over a total of 48 weeks will aid in the overall maintenance of bone health and may ameliorate bone density loss.
144 healthy postmenopausal women (≥ 40 to < 60 years old) in the U.S. who are experiencing menopause-related symptoms will be randomized to the study (12-week period), and a subset (72 postmenopausal women) will continue the study for an additional 36 weeks (Bone Health Study).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: ProbioticProbiotics in a capsule. |
| Placebo | Placebo comparator | Other: PlaceboNon active ingredients in a capsule. |
Who may qualify
- Ages
- 40 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy post-menopausal woman
- Last menstrual period has occurred at least 12 months prior to screening
- ≥40 to <60 years old
- Vaginal pH ≥ 5
- MRS score ≥ 20
Key exclusion criteria (19 listed)
- Milk or soy allergy
- Women with induced menopause through full or partial hysterectomy, chemotherapy or radiation
- Consumption of natural health products used to treat menopausal symptoms such as phytoestrogens, Black Cohosh, dehydroepiandrosterone (DHEA), Dong Quai, vitamin E (>250 IU/day), high consumption of soy food products, unless a 1-month wash-out period has been completed prior to study commencement
- Currently undergoing or have previously undergone HT for treatment of menopausal symptoms, unless a three-month washout has been completed prior to study commencement
- Active vaginal infections/abnormalities (e.g. active urinary tract infection (UTI), genital hemorrhage of unknown origin)
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 |
|---|---|---|
| ProbioticDosing regimen of one capsule daily for a maximum of 48 weeks. | Dietary supplement | Probiotic |
| PlaceboDosing regimen of one capsule daily for a maximum of 48 weeks. | Other | Placebo |
Primary outcome
Change from baseline in the global Menopause Rating Scale (MRS) score
Time frame: Measured on weeks -2 (screening visit), 0, 4, 8, 12, and 48.
Assessed using Menopause Rating Scale (MRS) rating scale. 11 questions on a scale from no complaints (0) to very severe symptoms (4). Subscores are added to create a composite or total score. A higher score indicates a greater severity of menopausal symptoms.
8 secondary outcomes
Change from baseline in individual components of the Menopause Rating Scale (MRS) (psychological, somatic and urogenital symptoms)
Time frame: Measured on weeks -2 (screening visit), 0, 4, 8, 12, and 48.
Change from baseline in vaginal pH
Time frame: Measured on weeks -2 (screening visit), 0, and 12.
Change from baseline in vaginal microbiota
Time frame: Measured on weeks 0 and 12.
Change from baseline in the Patient Health Questionnaire (PHQ-9) total score
Time frame: Measured on weeks 0, 4, 8, 12, and 48.
Change from baseline in the Pittsburgh Sleep Quality Index (PSQI) global score
Time frame: Measured on weeks 0, 4, 8, 12, and 48.
Change from baseline in the Vulvovaginal Symptoms Questionnaire (VSQ) total score.
Time frame: Measured on weeks 0, 4, 8, 12, and 48.
Change in baseline in the Michigan Incontinence Symptom Index (M-ISI) mean score
Time frame: Measured on weeks 0, 4, 8, 12, and 48.
Change from baseline in the Generalized Anxiety Disorder-7 (GAD-7) total score
Time frame: Measured on weeks 0, 4, 8, 12, and 48.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotic in people with Menopause, run by Lallemand Health Solutions at 5 sites in United States.
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 19 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: finished, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the global Menopause Rating Scale (MRS) score (time frame: Measured on weeks -2 (screening visit), 0, 4, 8, 12, and 48.). 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 2 Feb 2023.