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

Completed · Phase 2 · Has a placebo group

Conditions studied: Menopause

In brief

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.

Key facts

Study ID

NCT04001088

Run by

Lallemand Health Solutions

People needed

144

Starts

2019-07-29

Expected to finish

2021-04-23

Last updated by the study team

2023-02-02

Who can join

Age: 40 and older, up to 59. Sex: female. Healthy volunteers: accepted.

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)
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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