Microbial ColonizationPROSALVAGNCT05176535
Determination of Vaginal Colonization and the Effect of an Oral Probiotic (PROSALVAG)
A study testing FertyBiotic Balance in people with Microbial Colonization and Dysbiosis, run by Fertypharm at 1 site in Spain.
Trial summary
The aim of this study is to determine the efficacy of an oral nutraceutical with probiotics in restore vaginal health. Read more about this study
- Who is it for?
- Ages 35 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization, Dysbiosis, Fertility Issues
- What is being tested?
- FertyBiotic Balance
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- 11 Oct 2021to 28 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- Pregnant women
- Breastfeeding
- Use of intrauterine device
- Use of spermicide
- Use of cervical caps as hormonal therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Microbial Colonization, Dysbiosis, Fertility Issues
- Being tested
- FertyBiotic Balance
- Medical subject headings
- Communicable Diseases, Dysbiosis, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FertyBiotic BalanceDietary supplement
Lactobacillus rhamnosus BPL 205, Lactobacillus plantarum BPL207 and Lactobacillus crispatus BPL209
| Study group | Role | What they receive |
|---|---|---|
| FertyBiotic Balance | Experimental | Participants received FertyBiotic Balance one capsule a day Receives: Dietary Supplement: FertyBiotic Balance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in vaginal health
The restoration of vaginal health has been measured using three parameters: vaginal pH, citology and rectal and vaginal microbiome
Measured: 10 weeks
Secondary outcomes (2)
Autoinmune capacity
Autoinmune capacity will be evaluated by measuring plasma levels of IL-10, TNF- alpha and IL-10
Measured: 10 weeks
Antioxidant effect
Antioxidant will be evaluated by measuring Total Antioxidant Capacity (TAC) and Malondialdehyde
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start11 Oct 2021
- Primary completion15 Jan 2024
- Study completion28 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fertypharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05176535
- Sponsor's protocol ID
- 2021-FBB-07
- Acronym
- PROSALVAG
- Status last verified
- Jul 2025
- First submitted
- 30 Nov 2021
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Determine Vaginal Colonization and Effect of an Oral Probiotic That Contains L.Rhamnosus, L. Plantarum and L. Crispatus in Women (PROSALVAG)
- ClinicalTrials.gov ID
- NCT05176535
- Acronym / sponsor ID
- PROSALVAG / 2021-FBB-07
- Conditions
- Microbial Colonization, Dysbiosis, Fertility Issues
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- FertypharmIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 28 May 2024 (actual)
- First posted
- 4 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FertyBiotic Balance | Experimental | Dietary Supplement: FertyBiotic BalanceParticipants received FertyBiotic Balance one capsule a day |
Who may qualify
- Ages
- 35 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FertyBiotic BalanceLactobacillus rhamnosus BPL 205, Lactobacillus plantarum BPL207 and Lactobacillus crispatus BPL209 | Dietary supplement | FertyBiotic Balance |
Primary outcome
Improvement in vaginal health
Time frame: 10 weeks
The restoration of vaginal health has been measured using three parameters: vaginal pH, citology and rectal and vaginal microbiome
2 secondary outcomes
Autoinmune capacity
Time frame: 10 weeks
Antioxidant effect
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FertyBiotic Balance in people with Microbial Colonization and Dysbiosis, run by Fertypharm at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in vaginal health (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.