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

NCT04001088 | Completed Phase 2

• 1 other identifier: MPS
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 5

Brief 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

Menopause

Keywords

Probiotics; Menopausal symptoms; Bone health; Vulvar and vaginal atrophy; Vaginal microflora; Anxiety; Depression; Urinary incontinence; Metabolic syndrome biomarkers; Sleep quality; Gut microflora; Bone resorption markers; Bone formation markers; Bone Mineral Density (BMD); Fracture risk assessment

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the global Menopause Rating Scale (MRS) score

  Assessed using Menopause Rating Scale (MRS) rating scale. 11 questions on a scale from no complaints (0) to very severe symptoms (4). Subscores are added to create a composite or total score. A higher score indicates a greater severity of menopausal symptoms.

  Measured on weeks -2 (screening visit), 0, 4, 8, 12, and 48.

Secondary Outcomes (8)

• Change from baseline in individual components of the Menopause Rating Scale (MRS) (psychological, somatic and urogenital symptoms)

  Measured on weeks -2 (screening visit), 0, 4, 8, 12, and 48.

• Change from baseline in vaginal pH

  Measured on weeks -2 (screening visit), 0, and 12.

• Change from baseline in vaginal microbiota

  Measured on weeks 0 and 12.

• Change from baseline in the Patient Health Questionnaire (PHQ-9) total score

  Measured on weeks 0, 4, 8, 12, and 48.

• Change from baseline in the Pittsburgh Sleep Quality Index (PSQI) global score

  Measured on weeks 0, 4, 8, 12, and 48.

Other Outcomes (6)

• Change from baseline in levels of Metabolic Syndrome biomarkers (serum cholesterol [total, LDL, HDL], serum Triglycerides)

  Measured on weeks 0, 12, 24, and 48.

• Change in baseline of levels of pro-inflammatory cytokines Interleukin-17 (IL-17), RANKL and Tumor Necrosis Factor (TNF)

  Measured on weeks 0, 12, 24, and 48.

• Change from baseline in gut microflora

  Measured on weeks 0, 12, 24, and 48.

Study Arms (2)

Probiotic

EXPERIMENTAL

Probiotics in a capsule.

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Non active ingredients in a capsule.

Other: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

Dosing regimen of one capsule daily for a maximum of 48 weeks.

Probiotic

Placebo OTHER

Dosing regimen of one capsule daily for a maximum of 48 weeks.

Placebo

Eligibility Criteria

• Age: 40 Years - 59 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy post-menopausal woman
• Last menstrual period has occurred at least 12 months prior to screening
• ≥40 to \<60 years old
• Vaginal pH ≥ 5
• MRS score ≥ 20
• Willing and able to give written informed consent
• Willing to consume IP or placebo, complete questionnaires, records, and daily diaries associated with the study and to complete all clinical study visits
• Willingness to discontinue consumption of probiotic supplements and food containing added probiotics and/or prebiotics (e.g. yogurts with live, active cultures or supplements) o Note: Screened participants will be eligible to participate after completing a 4-week wash-out period.

You may not qualify if:

• Milk or soy allergy
• Women with induced menopause through full or partial hysterectomy, chemotherapy or radiation
• Consumption of natural health products used to treat menopausal symptoms such as phytoestrogens, Black Cohosh, dehydroepiandrosterone (DHEA), Dong Quai, vitamin E (\>250 IU/day), high consumption of soy food products, unless a 1-month wash-out period has been completed prior to study commencement
• Currently undergoing or have previously undergone HT for treatment of menopausal symptoms, unless a three-month washout has been completed prior to study commencement
• Active vaginal infections/abnormalities (e.g. active urinary tract infection (UTI), genital hemorrhage of unknown origin)
• o Note: Screened participants with infections would be eligible to participate 4 weeks after completing their course of treatment (wash-out period).
• Use of any vaginal medication, vaginal rinses and/or moisturizers, gels containing xylocaine or other analgesic products to decrease pain during intercourse, 1 week before and during study
• Use of any antibiotic drug within 1 month of screening
• o Note: Screened participants could be eligible to participate after a 2-week wash-out period.
• Participants previously diagnosed with hyperparathyroidism and/or hyperthyroidism
• Participation in other clinical studies in the past 6 months
• History of alcohol or drug abuse in the 12 months prior to screening
• History of cancer (except localized skin cancer without metastases) within five (5) years prior to screening
• History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the potential subject at risk because of participation in the study, or influences the results or the potential subject's ability to participate in the study
• History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs (i.e. Crohn's disease, short bowel, acute or chronic pancreatitis or pancreatic insufficiency)

Sponsors & Collaborators

• Lallemand Health Solutions: lead
• Nutrasource Pharmaceutical and Nutraceutical Services, Inc.: collaborator

Study Sites (5)

Altus Research

Lake Worth, Florida, 33461, United States

Location

Health Awareness Inc.

Port Saint Lucie, Florida, 34952, United States

Location

NeuroTrials Research Inc.

Atlanta, Georgia, 30342, United States

Location

Viable Research

Henderson, Nevada, 89014, United States

Location

Albuquerque Clinical Trials

Albuquerque, New Mexico, 87102, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression; Urinary Incontinence; Sleep Initiation and Maintenance Disorders

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: June 27, 2019
• Study Start: July 29, 2019
• Primary Completion: November 18, 2020
• Study Completion: April 23, 2021
• Last Updated: February 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)