Determination of Vaginal Colonization and the Effect of an Oral Probiotic (PROSALVAG)

Not Applicable

• Conditions: Microbial Colonization; Fertility Issues; Dysbiosis
• Interventions: Dietary Supplement: FertyBiotic Balance

• Registration Number: NCT05176535
• Lead Sponsor: Fertypharm

Brief Summary

The aim of this study is to determine the efficacy of an oral nutraceutical with probiotics in restore vaginal health.

Detailed Description

After being informed about the study, all patients meeting the inclusion/exclusion criteria and giving written informed consent will receive a nutraceutical containing L. rhamnosus, L. plantarum and L. crispatus once daily.

Study Timeline

• Study Start: 2021-10-11
• Status Verified: 2021-11
• Study First Submitted: 2021-11-30
• Study First Submitted QC: 2021-12-14
• Last Update Submitted: 2021-12-14
• Study First Posted: 2022-01-04
• Last Update Posted: 2022-01-04
• Primary Completion: 2022-10-11
• Study Completion: 2023-03-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 55

Inclusion Criteria

• Aged: 35-43 years old
• Vaginal pH > 4,5 and low Lactobacillus count or Nugent score of 4-6
• With interest in getting pregnant and ideally in IVF waiting list
• History of recurrent genitourinary infections

Exclusion Criteria

• Any pathology that interferes with the study
• Current intake of food supplements or probiotics
• Current intake of contraceptives
• Use of oral or vaginal probiotics in the last 6 months
• Hypersensitivity to any of the components of the studied product
• Current vaginal infection
• Pregnant women
• Breastfeeding
• Use of intrauterine device
• Use of spermicide
• Use of cervical caps as hormonal therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FertyBiotic Balance	FertyBiotic Balance	Participants received FertyBiotic Balance one capsule a day

Primary Outcome Measures

Name	Time	Method
Rectal and vaginal colonization	10 weeks	Rectal and vaginal colonization will be evaluated by measuring massive sequencing of 16SrRNA gen

Secondary Outcome Measures

Name	Time	Method
Antioxidant effect	10 weeks	Antioxidant will be evaluated by measuring Total Antioxidant Capacity (TAC) and Malondialdehyde
Autoinmune capacity	10 weeks	Autoinmune capacity will be evaluated by measuring plasma levels of IL-10, TNF- alpha and IL-10

Trial Locations

Locations (1)

HM Fertility Centter Vallés; 🇪🇸 Alcalá De Henares, Madrid, Spain