Impact of a Probiotic Combination on Quality of Life and Symptoms in Peri- and Postmenopausal Women (NCT06604234) | Clinical Trial Compass
CompletedNot Applicable
Impact of a Probiotic Combination on Quality of Life and Symptoms in Peri- and Postmenopausal Women
Spain245 participantsStarted 2024-09-16
Plain-language summary
In this randomized, placebo-controlled, double-blind study, we aim to investigate if the active product consisting of a probiotic blend can improve the quality of life and alleviate symptoms in peri- and postmenopausal women, using validated questionnaires.
Who can participate
Age range45 Years – 60 Years
SexFEMALE
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Inclusion criteria
✓. Women in peri- and/or postmenopause period (up to 5 years after last menstruation) Perimenopause is defined as if changes in the menstrual cycle (such as longer or shorter cycles, absence of any menstrual cycle, or abnormally heavy or prolonged bleeding) have occurred in the previous 12 months.
✓. Age 45-60 years.
✓. Cervantes quality of life scale score ≥ 38 at the screening visit.
✓. Willing to sign the informed consent.
✓. Willing to maintain dietary or lifestyle habits during the study.
Exclusion criteria
✕. Regular use of probiotics other than the probiotics under study (in the form of food supplements or in foods such as "bifidus" type yogurt) in the month prior to the baseline visit.
✕. Use of oral or injectable antibiotics in the last month before the start of the study.
✕. Women with history of hysterectomy (removal of the uterus) or ovariectomy (removal of the ovaries).
✕. Diagnosis of active oncological disease.
✕. Use of hormone replacement therapy (HRT), hormonal analogues or oral contraceptives in the 3 months prior to the start of the study.
✕. Type 1 diabetes.
✕. Untreated or unstable thyroid disease.
What they're measuring
1
Quality of life measured by the Cervantes Scale
Timeframe: Baseline, 30 days, 60 days, 90 days
2
Menopause-related symptoms evaluated by Menopause Rating Scale (MRS) scale