Impact of a Probiotic Combination on Quality of Life and Symptoms in Peri- and Postmenopausal Women

Last updated: March 11, 2025
Sponsor: AB Biotics, SA
Overall Status: Completed

Phase

N/A

Condition

Menopause

Treatment

Placebo

Probiotic

Clinical Study ID

NCT06604234
AB-GynMeno-24
  • Ages 45-60
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 orshorter cycles, absence of any menstrual cycle, or abnormally heavy or prolongedbleeding) 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

Exclusion Criteria:

  1. 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.

  2. Use of oral or injectable antibiotics in the last month before the start of thestudy.

  3. Women with history of hysterectomy (removal of the uterus) or ovariectomy (removalof the ovaries).

  4. Diagnosis of active oncological disease.

  5. Use of hormone replacement therapy (HRT), hormonal analogues or oral contraceptivesin 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 (Crohnsdisease, 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.

Study Design

Total Participants: 244
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
September 16, 2024
Estimated Completion Date:
January 17, 2025

Study 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.

Connect with a study center

  • HM Gabinete Velázquez

    Madrid, 28001
    Spain

    Site Not Available

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