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OpenTrials
Completed

NCT Number: NCT05176535

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

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

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Key information

Conditions

Microbial Colonization Communicable Diseases Disease Attributes Dysbiosis Fertility Issues Genital Diseases Infections Infertility Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases

Age range

35 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

HM Fertility Centter Vallés

Alcalá de Henares, Madrid, 28801, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FertyBiotic Balance

Dietary Supplement

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

Primary outcomes

  1. Rectal and vaginal colonization

    Time frame: 10 weeks

    Rectal and vaginal colonization will be evaluated by measuring massive sequencing of 16SrRNA gen

Secondary outcomes

  1. Autoinmune capacity

    Time frame: 10 weeks

    Autoinmune capacity will be evaluated by measuring plasma levels of IL-10, TNF- alpha and IL-10

  2. Antioxidant effect

    Time frame: 10 weeks

    Antioxidant will be evaluated by measuring Total Antioxidant Capacity (TAC) and Malondialdehyde

Sponsors and collaborators

Lead sponsor

Fertypharm

Industry

Registry information

Official study title

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

Acronym: PROSALVAG

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 4, 2022
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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