Status:
COMPLETED
A Randomized-Controlled Trial to Examine the Effects of a Daily Probiotic Supplement on Common Symptoms of Menopause
Lead Sponsor:
Maneuver Marketing
Collaborating Sponsors:
Citruslabs
Conditions:
Menopause
Eligibility:
FEMALE
45-65 years
Phase:
NA
Brief Summary
Symptoms of menopause can significantly affect overall quality of life. It is hypothesized that probiotic supplements can reduce the severity of these symptoms. This 90-day randomized controlled trial...
Eligibility Criteria
Inclusion
- Women aged 45-65 years old
- Must experience hot flashes and/or night sweats at least once per day
- Must also be experiencing at least two symptoms of menopause, such as sleep disturbances, mood changes, fatigue and lack of energy, changes in sexual function, urinary changes, weight gain, or vaginal changes
- Can be either natural or surgical menopause
- Has not had a period in the last 12 consecutive months
- Willing to adhere to the study protocol for the duration of the study
- Willing to stop taking any other herbal remedies or supplements for the duration of the study
- Self-reports as "generally healthy"
- Has never taken Provitalize before
- No planned invasive medical procedures for the duration of the study or in the three weeks leading up to the study start
Exclusion
- Not experiencing hot flashes and/or night sweats at least once per day and two other symptoms of menopause such as sleep disturbances, mood changes, fatigue and lack of energy, changes in sexual function, urinary changes, irregular or absent periods, or vaginal changes
- Unwilling to stop taking any other herbal remedies or supplements for the duration of the study
- Current use of conventional hormone replacement therapies, or plan to start during the study duration
- Current use of hormonal birth control, or plan to start during the study duration
- Known allergies or hypersensitivities to any product ingredients
- Current or history of uterine fibroids, endometriosis, polycystic ovarian syndrome, or history of abnormal pap smear
- Anyone with any known severe allergies requiring the use of an epi-pen
- Unwilling to adhere to the study protocol
- Anyone living with uncontrolled or chronic health disorders, including oncological or psychiatric disorders
- Pregnant, breastfeeding or trying to conceive
- Currently taking a prescription sleep aid
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06148714
Start Date
December 1 2023
End Date
June 15 2024
Last Update
November 20 2024
Active Locations (1)
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1
Citruslabs
Santa Monica, California, United States, 90404