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The Effects of a Novel Probiotic Supplement on Menopausal Symptoms and Bone Health — MPS  

Menopause Clinical Trial

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

Clinical 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04001088
Study type Interventional
Source Lallemand Health Solutions
Contact
Status Completed
Phase Phase 2
Start date July 29, 2019
Completion date April 23, 2021
View Details
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