| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Menopause | Dietary Supplement: Probiotic Other: Placebo | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 144 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Supportive Care |
| 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 |
| Actual Study Start Date : | July 29, 2019 |
| Actual Primary Completion Date : | December 31, 2020 |
| Estimated Study Completion Date : | June 15, 2021 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Probiotic
Probiotics in a capsule.
|
Dietary Supplement: Probiotic
Dosing regimen of one capsule daily for a maximum of 48 weeks.
|
|
Placebo Comparator: Placebo
Non active ingredients in a capsule.
|
Other: Placebo
Dosing regimen of one capsule daily for a maximum of 48 weeks.
|
| Ages Eligible for Study: | 40 Years to 59 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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).
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.
| United States, Florida | |
| Altus Research | |
| Lake Worth, Florida, United States, 33461 | |
| Health Awareness Inc. | |
| Port Saint Lucie, Florida, United States, 34952 | |
| United States, Georgia | |
| NeuroTrials Research Inc. | |
| Atlanta, Georgia, United States, 30342 | |
| United States, Nevada | |
| Viable Research | |
| Henderson, Nevada, United States, 89014 | |
| United States, New Mexico | |
| Albuquerque Clinical Trials | |
| Albuquerque, New Mexico, United States, 87102 | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 25, 2019 | ||||
| First Posted Date ICMJE | June 27, 2019 | ||||
| Last Update Posted Date | May 19, 2021 | ||||
| Actual Study Start Date ICMJE | July 29, 2019 | ||||
| Actual Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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.
|
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures |
|
||||
| Original Other Pre-specified Outcome Measures | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Effects of a Novel Probiotic Supplement on Menopausal Symptoms and Bone Health | ||||
| Official Title ICMJE | The Effects of a Novel Probiotic Supplement on Menopausal Symptoms and Bone Health: A Randomized, Double-blind, Parallel, Placebo-Controlled, Multi-Centre Study | ||||
| Brief 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. | ||||
| 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 Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
||||
| Condition ICMJE | Menopause | ||||
| Intervention ICMJE |
|
||||
| Study Arms ICMJE |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE |
144 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | June 15, 2021 | ||||
| Actual Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender ICMJE |
|
||||
| Ages ICMJE | 40 Years to 59 Years (Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04001088 | ||||
| Other Study ID Numbers ICMJE | MPS | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement ICMJE |
|
||||
| Responsible Party | Lallemand Health Solutions | ||||
| Study Sponsor ICMJE | Lallemand Health Solutions | ||||
| Collaborators ICMJE | Nutrasource Diagnostics Inc. | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Lallemand Health Solutions | ||||
| Verification Date | May 2021 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||