Vaginal FloraNCT03923985
Clinical Trial to Evaluate the Effect of an Oral Probiotic on the Vaginal Flora
A study testing Probiotic containing Lactobacillus Crispatus in people with Vaginal Flora, run by Instituto Palacios at 1 site in Spain.
Trial summary
Clinical trial to evaluate the effect of a probiotic containing Lactobacillus Crispatus on the vaginal flora Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Flora
- What is being tested?
- Probiotic containing Lactobacillus Crispatus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 21 Mar 2019to 30 Oct 2019
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women between 18 and 45 years old
- Women without current symptoms of vaginal infection
- Negative bacteriological and clinical examination
Who cannot join
- Women with vaginal infection
- Women with undiagnosed vaginal bleeding
- Patients with endometrial hyperplasia
- Suspicion of neoplasia or active neoplasia
- Women with intolerance, allergy or hypersensitivity to the components of the probiotic
- Women with immunosuppressive disorders or with HIV
Show all 10Show fewer
- Women who are currently using probiotics by any route of administration
- Women who are using some treatment for vaginal sepsis
- Chronic decompensated noncommunicable diseases (diabetes mellitus, heart disease ...)
- Pregnant women or those with precocious menopause
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial to Evaluate the Effect of an Oral Probiotic (Food Supplement) Containing Lactobacillus Crispatus on the Vaginal Flora
Clinical trial to evaluate the effect of a probiotic containing Lactobacillus Crispatus on the vaginal flora
- Conditions
- Vaginal Flora
- Being tested
- Probiotic containing Lactobacillus Crispatus
- Keywords
- Vaginal Flora, Oral Probiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic containing Lactobacillus CrispatusDietary supplement
1 tablet / day of probiotic (275 mg of live probiotic lactic ferments: 10 Mld L. fermentum (SGL 10), 10 Mld L. gasseri, 10 Mld L. casei, 10 Mld L. acidophilus, 10 Mld L. crispatus) during 2 months.
| Study group | Role | What they receive |
|---|---|---|
| Active Arm | Active comparator | 1 tablet / day of probiotic containing 10 Mld L. crispatus during two months Receives: Dietary Supplement: Probiotic containing Lactobacillus Crispatus |
| Control Arm | No intervention | No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the number of Lactobacillus Crispatus on the vaginal flora
Analysis of vaginal lactobacilli.
Measured: Screening, month 2
Secondary outcomes (1)
Changes in vaginal PH
PH measurement
Measured: Screening, month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start21 Mar 2019
- Primary completion30 Sep 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal FloraStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Palacios
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Santiago Palacios, PhD, Principal investigator, Instituto Palacios
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03923985
- Sponsor's protocol ID
- SEID-Probiot
- Status last verified
- Feb 2021
- First submitted
- 5 Apr 2019
- Last updated
- 11 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate the Effect of an Oral Probiotic (Food Supplement) Containing Lactobacillus Crispatus on the Vaginal Flora
- ClinicalTrials.gov ID
- NCT03923985
- Acronym / sponsor ID
- SEID-Probiot
- Conditions
- Vaginal Flora
- Keywords
- Vaginal Flora, Oral Probiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Instituto PalaciosUniversity, hospital or other
- Study start
- 21 Mar 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 23 Apr 2019 (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.
Clinical trial to evaluate the effect of a probiotic containing Lactobacillus Crispatus on the vaginal flora
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Arm | Active comparator | Dietary Supplement: Probiotic containing Lactobacillus Crispatus1 tablet / day of probiotic containing 10 Mld L. crispatus during two months |
| Control Arm | No intervention | –No treatment |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy women between 18 and 45 years old
- Women without current symptoms of vaginal infection
- Negative bacteriological and clinical examination
Key exclusion criteria (10 listed)
- Women with vaginal infection
- Women with undiagnosed vaginal bleeding
- Patients with endometrial hyperplasia
- Suspicion of neoplasia or active neoplasia
- Women with intolerance, allergy or hypersensitivity to the components of the probiotic
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 |
|---|---|---|
| Probiotic containing Lactobacillus Crispatus1 tablet / day of probiotic (275 mg of live probiotic lactic ferments: 10 Mld L. fermentum (SGL 10), 10 Mld L. gasseri, 10 Mld L. casei, 10 Mld L. acidophilus, 10 Mld L. crispatus) during 2 months. | Dietary supplement | Active Arm |
Primary outcome
Changes in the number of Lactobacillus Crispatus on the vaginal flora
Time frame: Screening, month 2
Analysis of vaginal lactobacilli.
1 secondary outcome
Changes in vaginal PH
Time frame: Screening, month 2
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 11 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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.
Santiago Palacios, PhD principal investigator
Instituto Palacios
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic containing Lactobacillus Crispatus in people with Vaginal Flora, run by Instituto Palacios 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 3 inclusion and 10 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 11 Feb 2021. 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?
Changes in the number of Lactobacillus Crispatus on the vaginal flora (time frame: Screening, month 2). 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 11 Feb 2021.