A Randomized-Controlled Trial to Examine the Effects of a Daily Probiotic Supplement on Common Symptoms of Menopause

What this trial studies

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 will examine the effects of the Provitalize Natural Menopause Probiotic on weight loss, waist circumference, sleep, and symptoms of menopause including hot flashes, night sweats, mood swings, anxiety, fatigue and brain fog. Participants will take either the test product or a placebo daily.

Conditions in scope

• Menopause

Interventions

• Provitalize Natural Menopause Probiotic (Dietary Supplement) — Supplement containing a Probiotic blend of Bifidobacterium breve, Lactobacillus Gasseri, and Bifidobacterium animalis subsp. Lactis.
• Placebo (Other) — Placebo comparator containing Pure hydroxypropyl methylcellulose (HPmC) with food dye.

Who can join

Women only · Ages 45 Years to 65 Years · Accepts healthy volunteers.

Inclusion criteria

• 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"

Exclusion criteria

• 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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: N/A
• Start date: 2023-12-01
• Primary completion: 2024-06-15
• Last update posted: 2024-11-20
• First posted: 2023-11-28

Sponsor & contact

Lead sponsor: Maneuver Marketing (Industry)

Collaborators: Citruslabs

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Change in body weight. [Timeframe: Baseline to Day 90] (90 days)
  Participants will weigh themselves using a Fitbit Smart Scale that they will be provided with.
• Change in waist circumference. [Timeframe: Baseline to Day 90] (90 days)
  Participants will measure their waist circumference using a tape measure that they will be provided with.
• Changes in scores on the Bristol Stool Chart. [Timeframe: Baseline to Day 90] (90 days)
  The Bristol Stool Chart is widely used as a research tool to evaluate the effectiveness of treatments for various diseases of the bowel. Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools as they are easy to defecate while not containing excess liquid, 5 indicating lack of dietary fiber, and 6 and 7 indicate diarrhoea.

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.