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

Study to Determine Vaginal Colonization and Effect of an Oral Probiotic That Contains L.Rhamnosus, L. Plantarum and L. Crispatus in Women (PROSALVAG)

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

Study Overview

• Status: Completed
• Conditions: Microbial Colonization; Dysbiosis; Fertility Issues
• Intervention / Treatment: Dietary supplement: FertyBiotic Balance

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Alcalá de Henares, Madrid, Spain, 28801
      • HM Fertility Centter Vallés

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 43 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FertyBiotic Balance; Participants received FertyBiotic Balance one capsule a day	Dietary supplement: FertyBiotic Balance; Lactobacillus rhamnosus BPL 205, Lactobacillus plantarum BPL207 and Lactobacillus crispatus BPL209

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rectal and vaginal colonization	Rectal and vaginal colonization will be evaluated by measuring massive sequencing of 16SrRNA gen	10 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fertypharm

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2021
• Primary Completion (Actual): January 15, 2024
• Study Completion (Actual): May 28, 2024

Study Registration Dates

• First Submitted: November 30, 2021
• First Submitted That Met QC Criteria: December 14, 2021
• First Posted (Actual): January 4, 2022

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Disease Attributes; Infections; Pathological Conditions, Signs and Symptoms; Dysbiosis; Communicable Diseases; Infertility
• Other Study ID Numbers: 2021-FBB-07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No