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

NCT ID: NCT05176535

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-11

Study Completion Date

2024-05-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Microbial Colonization Dysbiosis Fertility Issues

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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FertyBiotic Balance

Participants received FertyBiotic Balance one capsule a day

Group Type EXPERIMENTAL

FertyBiotic Balance

Intervention Type DIETARY_SUPPLEMENT

Lactobacillus rhamnosus BPL 205, Lactobacillus plantarum BPL207 and Lactobacillus crispatus BPL209

Interventions

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FertyBiotic Balance

Lactobacillus rhamnosus BPL 205, Lactobacillus plantarum BPL207 and Lactobacillus crispatus BPL209

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

43 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fertypharm

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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HM Fertility Centter Vallés

Alcalá de Henares, Madrid, Spain

Site Status

Countries

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Spain

Other Identifiers

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2021-FBB-07

Identifier Type: -

Identifier Source: org_study_id

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