NCT04001088

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

The Effects of a Novel Probiotic Supplement on Menopausal Symptoms and Bone Health: A Randomized, Double-blind, Parallel, Placebo-Controlled, Multi-Centre Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Lallemand Health Solutions · Industry
• Sex: Female
• Age: 40 Years – 59 Years
• Healthy volunteers: Accepted

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).

Conditions

• Menopause

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	Dosing regimen of one capsule daily for a maximum of 48 weeks.
OTHER	Placebo	Dosing regimen of one capsule daily for a maximum of 48 weeks.

Timeline

• Start date: 2019-07-29
• Primary completion: 2020-11-18
• Completion: 2021-04-23
• First posted: 2019-06-27
• Last updated: 2023-02-02

Locations

5 sites across 1 country: United States