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Probiotic

The Effects of a Novel Probiotic Supplement on Menopausal Symptoms and Bone Health (MPS Trial)

Phase 2
Waitlist Available
Research Sponsored by Lallemand Health Solutions
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured on weeks -2 (screening visit), 0, 4, 8, 12, and 48.

Summary

This trial is testing a probiotic supplement to see if it can reduce menopause symptoms and support bone health in women experiencing menopause. The supplement aims to improve the balance of good bacteria in the body. The study involves 144 women with menopause-related symptoms. Probiotics have been studied for their potential to prevent or treat menopause-related diseases.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured on weeks -2 (screening visit), 0, 4, 8, 12, and 48.
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured on weeks -2 (screening visit), 0, 4, 8, 12, and 48. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in the global Menopause Rating Scale (MRS) score
Secondary study objectives
Change from baseline in individual components of the Menopause Rating Scale (MRS) (psychological, somatic and urogenital symptoms)
Change from baseline in the Generalized Anxiety Disorder-7 (GAD-7) total score
Change from baseline in the Patient Health Questionnaire (PHQ-9) total score
+5 more
Other study objectives
Change from baseline in dual-energy X-ray Absorptiometry (DXA) scans
Change from baseline in gut microflora
Change from baseline in levels of Metabolic Syndrome biomarkers (serum cholesterol [total, LDL, HDL], serum Triglycerides)
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ProbioticExperimental Treatment1 Intervention
Probiotics in a capsule.
Group II: PlaceboPlacebo Group1 Intervention
Non active ingredients in a capsule.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Probiotic
2013
Completed Phase 4
~3570

Find a Location

Who is running the clinical trial?

Lallemand Health SolutionsLead Sponsor
41 Previous Clinical Trials
3,832 Total Patients Enrolled
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.NETWORK
36 Previous Clinical Trials
1,958 Total Patients Enrolled
~23 spots leftby Dec 2025
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