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Clinical Trials/ISRCTN15737648
ISRCTN15737648
Completed
未知

Observational prospective study on the efficacy of a food supplement containing a probiotic blend to restore the physiological vaginal microbiota in postmenopausal women

SynBalance srl0 sites50 target enrollmentOctober 6, 2022
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ConditionsVaginal dysbiosis and vaginal infectionsUrological and Genital Diseases

Overview

Phase
未知
Intervention
Not specified
Conditions
Vaginal dysbiosis and vaginal infections
Sponsor
SynBalance srl
Enrollment
50
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

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

Registry
who.int
Start Date
October 6, 2022
End Date
March 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
SynBalance srl

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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