Phase
Condition
Menopause
Treatment
Placebo
Probiotic
Clinical Study ID
Ages 45-60 Female
Study Summary
Eligibility Criteria
Inclusion
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 orshorter cycles, absence of any menstrual cycle, or abnormally heavy or prolongedbleeding) 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
Exclusion Criteria:
Regular use of probiotics other than the probiotics under study (in the form of foodsupplements or in foods such as "bifidus" type yogurt) in the month prior to thebaseline visit.
Use of oral or injectable antibiotics in the last month before the start of thestudy.
Women with history of hysterectomy (removal of the uterus) or ovariectomy (removalof the ovaries).
Diagnosis of active oncological disease.
Use of hormone replacement therapy (HRT), hormonal analogues or oral contraceptivesin 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 (Crohnsdisease, 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.
Study Design
Study Description
Connect with a study center
HM Gabinete Velázquez
Madrid, 28001
SpainSite Not Available
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