Clinical trial NCT06604234: Impact of a Probiotic Combination on Quality of Life and Symptoms in Peri- and Postmenopausal Women
Official title: Randomized, Double-blind, Placebo-controlled Study to Evaluate the Impact of the Combination of Three Probiotic Strains on Quality of Life and Symptoms in Peri- and Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Keywords: Probiotic
Menopause
Quality of life
Lead sponsor: AB Biotics, SA
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 244
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Placebo-controlled study
Primary purpose: SUPPORTIVE_CARE

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, using validated questionnaires.

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 2:1) 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 (Menopause Rating Scale, MRS) and health-related quality of life (Utian Quality of Life). This will be documented through a specifically designed, web-based platform. Main study variable is change in the global score in MRS scores and Cervantes quality of life scores throughout study period.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Age 45-60 years.
3. Cervantes quality of life scale score ≥ 38 at the screening visit.
4. Willing to sign the informed consent.
5. Willing to maintain dietary or lifestyle habits during the study.

Exclusion Criteria:

1. 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.
2. Use of oral or injectable antibiotics in the last month before the start of the study.
3. Women with history of hysterectomy (removal of the uterus) or ovariectomy (removal of the ovaries).
4. Diagnosis of active oncological disease.
5. Use of hormone replacement therapy (HRT), hormonal analogues or oral contraceptives in the 3 months prior to the start of the study.
6. Type 1 diabetes.
7. Untreated or unstable thyroid disease.
8. Diagnosis of severe renal, cardiac or hepatic disease.
9. Diagnosis of chronic gastrointestinal disease: inflammatory bowel disease (Crohns disease, ulcerative colitis), pancreatitis, short bowel syndrome.
10. Diagnosis of celiac disease
11. Regular intake of laxatives such as polyethylene glycol or irritant laxatives (bisacodyl, sennosides, sodium pyrosulphate) (+3 days/week).
12. Primary or secondary immunodeficiency: AIDS, immunoglobulin deficiency.

Primary outcomes:
measure: Quality of life measured by the Cervantes Scale
timeFrame: Baseline, 30 days, 60 days, 90 days
measure: Menopause-related symptoms evaluated by Menopause Rating Scale (MRS) scale
timeFrame: Baseline, 30 days, 60 days, 90 days
Secondary outcomes:
measure: Quality of life measured by the Cervantes Scale subscores
timeFrame: Baseline, 30 days, 60 days, 90 days
measure: Menopause-related symptoms evaluated by MRS scale sub-scores
timeFrame: Baseline, 30 days, 60 days, 90 days
measure: Greene Climateric Scale
timeFrame: Baseline, 90 days
measure: Utian Quality of Life scale
timeFrame: Baseline, 90 days
measure: Gastrointestinal symptoms
timeFrame: Baseline, 90 days
measure: Symptoms vaginal infections
timeFrame: Baseline, 30 days, 60 days, 90 days
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: HM Gabinete Velázquez
Study officials:
affiliation: HM hospitales
name: Silvia González Rodríguez
role: PRINCIPAL_INVESTIGATOR
References:
citation: Honda S, Tominaga Y, Espadaler-Mazo J, Huedo P, Aguilo M, Perez M, Ueda T, Sawashita J. Supplementation with a Probiotic Formula Having beta-Glucuronidase Activity Modulates Serum Estrogen Levels in Healthy Peri- and Postmenopausal Women. J Med Food. 2024 Aug;27(8):720-727. doi: 10.1089/jmf.2023.k.0320. Epub 2024 Jun 16.