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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05176535

Acronym

PROSALVAG

Enrollment

Registered

2022-01-04

Start date

2021-10-11

Completion date

2024-05-28

Last updated

2025-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysbiosis, Fertility Issues, Microbial Colonization

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.

Interventions

DIETARY_SUPPLEMENTFertyBiotic Balance

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

35 Years to 43 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026