Status:
COMPLETED
Impact of a Probiotic Combination on Quality of Life and Symptoms in Peri- and Postmenopausal Women
Lead Sponsor:
AB Biotics, SA
Conditions:
Menopause
Eligibility:
FEMALE
45-60 years
Phase:
NA
Brief 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- ...
Detailed Description
Fifty to 80% of women around menopause or already in postmenopause complain about symptoms such as hot flashes, night sweats, sleep disturbances, tiredness, and depression, which negatively impact the...
Eligibility Criteria
Inclusion
- 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
- 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.
- Diagnosis of severe renal, cardiac or hepatic disease.
- Diagnosis of chronic gastrointestinal disease: inflammatory bowel disease (Crohns disease, ulcerative colitis), pancreatitis, short bowel syndrome.
- Diagnosis of celiac disease
- Regular intake of laxatives such as polyethylene glycol or irritant laxatives (bisacodyl, sennosides, sodium pyrosulphate) (+3 days/week).
- Primary or secondary immunodeficiency: AIDS, immunoglobulin deficiency.
Key Trial Info
Start Date :
September 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2025
Estimated Enrollment :
245 Patients enrolled
Trial Details
Trial ID
NCT06604234
Start Date
September 16 2024
End Date
January 17 2025
Last Update
December 4 2025
Active Locations (1)
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1
HM Gabinete Velázquez
Madrid, Madrid, Spain, 28001