Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06604234
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
Evaluate the Impact of the Combination of 3 Probiotic Strains on Quality of Life and Symptoms in Peri- and Postmenopausal Women
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Double-blind Placebo-controlled Study to Evaluate the Impact of the Combination of the Probiotics Levilactobacillus Brevis KABP-052 Lactiplantibacillus Plantarum KABP-051 and Pediococcus Acidilactici KABP-021 on Quality of Life and Symptoms in Peri- and Postmenopausal Women
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GynMeno
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- and postmenopausal women
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 their quality of life The aim of this study was to evaluate the effects of a multiprobiotic strain on the quality of life and menopause-associated symptoms The study is a de-centralized prospective randomized placebo-controlled double-blind study in which peri- and postmenopausal women will be recruited and randomly assigned ratio 21 to receive either a probiotic blend or placebo formulation in capsules form for 12 weeks We aim to recruit up to 300 women On a monthly basis quality of life will be evaluated by using the validated Spanish Quality of Life Cervantes questionnaire In addition other questionnaires will be administered to monitor menopause-related symptoms and health-related quality of life This will be documented through a specifically designed web-based platform Main study variable is change in the global score in Cervantes quality of life questionnaire throughout study period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None