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

NCT04001088 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2023-02-02

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

    collaborator NETWORK

  • Lallemand Health Solutions

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
59 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-29
Primary Completion
2020-11-18
Completion
2021-04-23

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04001088 on ClinicalTrials.gov