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

NCT ID: NCT04001088

Last Updated: 2023-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-29
• Study Completion Date: 2021-04-23

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Probiotic

Probiotics in a capsule.

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

Non active ingredients in a capsule.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

Probiotic

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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)
• History of a surgical procedure for the treatment of obesity (e.g., gastric bypass, gastric banding)
• Currently consuming more than 2 standard alcoholic beverages a day. A standard alcoholic beverage is defined as 12 ounces of beer, five (5) ounces of wine, or 1.5 ounces of liquor
• Difficulty swallowing large pills or large quantities of pills
• Any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the study data

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

NETWORK

Sponsor Role: collaborator

Lallemand Health Solutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Altus Research

Lake Worth, Florida, United States

Health Awareness Inc.

Port Saint Lucie, Florida, United States

NeuroTrials Research Inc.

Atlanta, Georgia, United States

Viable Research

Henderson, Nevada, United States

Albuquerque Clinical Trials

Albuquerque, New Mexico, United States

Countries

United States

Other Identifiers

MPS

Identifier Type: -

Identifier Source: org_study_id