Determination of Vaginal Colonization and the Effect of a... | NCT05176535

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

NCT05176535

Sponsor

Fertypharm

Status

Completed

Last Update Posted

Dec 4, 2025Actual

Enrollment

32Actual

Phase

Not Applicable

Conditions

Microbial Colonization
Dysbiosis
Fertility Issues

Interventions

FertyBiotic Balance

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 11, 2021Actual

Primary Completion Date

Jan 15, 2024Actual

Completion Date

May 28, 2024Actual

First Submitted Date

Nov 30, 2021

First Submission Date that Met QC Criteria

Dec 14, 2021

First Posted Date

Jan 4, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 26, 2025

Last Update Posted Date

Dec 4, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FertyBiotic Balance	Experimental	Participants received FertyBiotic Balance one capsule a day	Dietary Supplement: FertyBiotic Balance

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FertyBiotic Balance	Dietary Supplement	Lactobacillus rhamnosus BPL 205, Lactobacillus plantarum BPL207 and Lactobacillus crispatus BPL209	FertyBiotic Balance

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Restoration of vaginal microbiota

Minimum Age

35 Years

Maximum Age

43 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
HM Fertility Centter Vallés		Alcalá de Henares	Madrid	28801	Spain

Condition Browse Module

MeSH Terms

ID	Term
D003141	Communicable Diseases
D064806	Dysbiosis
D007246	Infertility

Ancestor Terms

ID	Term
D007239	Infections
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided