NCT05176535

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 11, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 4, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2024

Completed
Last Updated

December 4, 2025

Status Verified

July 1, 2025

Enrollment Period

2.3 years

First QC Date

November 30, 2021

Last Update Submit

November 26, 2025

Conditions

Microbial ColonizationDysbiosisFertility Issues

Outcome Measures

Primary Outcomes (1)

  • Rectal and vaginal colonization

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

    10 weeks

Secondary Outcomes (2)

  • Autoinmune capacity

    10 weeks

  • Antioxidant effect

    10 weeks

Study Arms (1)

FertyBiotic Balance

EXPERIMENTAL

Participants received FertyBiotic Balance one capsule a day

Dietary Supplement: FertyBiotic Balance

Interventions

FertyBiotic BalanceDIETARY_SUPPLEMENT

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

FertyBiotic Balance

Eligibility Criteria

Age35 Years - 43 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsRestoration of vaginal microbiota
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HM Fertility Centter Vallés

Alcalá de Henares, Madrid, 28801, Spain

Location

MeSH Terms

Conditions

Communicable DiseasesDysbiosisInfertility

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGenital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2021

First Posted

January 4, 2022

Study Start

October 11, 2021

Primary Completion

January 15, 2024

Study Completion

May 28, 2024

Last Updated

December 4, 2025

Record last verified: 2025-07

Locations

ES(1)