The effectiveness of a probiotic food supplement to restore the vaginal microbiota in postmenopausal wome

Not Applicable

Completed

• Conditions: Vaginal dysbiosis and vaginal infections; Urological and Genital Diseases

• Registration Number: ISRCTN15737648
• Lead Sponsor: SynBalance srl

Brief Summary

2024 Results article in https://doi.org/10.3390/nu16030402 (added 26/02/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-06
• Study Completion: 2023-03-31
• Last Update Posted: 11 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

1. Postmenopausal women, aged 45-65 years, with last menstrual cycle more than 18 months ago
2. Women with body mass index (BMI) =27 kg/m²
3. Women with vaginal pH =5
4. Postmenopausal women with typical menopausal disorders
5. Women who intend to use the probiotic product and undergo checkups

Exclusion Criteria

1. Women under hormone therapy (HT)
2. Women with BMI >27 kg/m²
3. Women who intend to use probiotic products or that used them in the last 2 weeks
4. Women with a proven allergy to the product
5. Women who have undergone antimicrobial treatment in the last 4 weeks

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composition of the vaginal microbiota. The effect of the probiotic treatment on the initial menopausal vaginal dysbiosis will be evaluated as an increase in lactobacillary presence and an improvement of healthy microbiota. Measured at baseline and 4 weeks.

Secondary Outcome Measures

Name	Time	Method
1. Vaginal pH measured using litmus paper at baseline and 4 weeks<br>2. Dosage of pro-inflammatory cytokines (IL-6, IL-1ß, TNF-a and IL-8) measured using human cytokine ELISA kits at baseline and 4 weeks<br>3. Vaginal well-being measured using the vaginal health index (VHI) at baseline, 4 and 8 weeks