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HealthyNCT05688397

Evaluation of the Vaginal Colonization of Two New Lactobacillus Strains After Oral Administration in Healthy Volunteers

A study testing Experimental 1 and Experimental 2 in people with Healthy, run by AB Biotics, SA at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Randomized study to determine whether the vaginally isolated strains of Lactobacillus gasseri and/or Lactobacillus crispatus can colonize the vagina when taken orally for 18 days. Secondary outcomes comprise evaluation of safety, tolerability, impact on vaginal microbiota and vaginal pH 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
Healthy
What is being tested?
Experimental 1 and Experimental 2
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteSpain
Study dates
15 Feb 2023to 30 Jun 2023
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
  • Reproductive age 18-45 years

Who cannot join

  • Vaginal infection or symptoms (AMSEL criteria).
  • Relevant disease (immunodeficiency, cervicovaginal pathology, diabetes, estrogen-dependent tumors, inflammatory bowel disease, atrophic vaginitis, pancreatitis)
  • Suffer from chronic diarrhea or constipation or short bowel syndrome,
  • Having taken systemic or vaginal antibiotics or antifungals during the month prior to study entry.
  • Pregnant women or willing to be during the study, lactating women.
  • Having taken another probiotic during the month prior to study entry orally or vaginally. This includes food supplements or foods supplemented with probiotics such as Actimel, Activia or similar.
Show all 15Show fewer
  • Intake of immunomodulators or systemic corticosteroids.
  • History of alcohol or drug abuse.
  • Menopausal women.
  • Use of the IUD.
  • Use of spermicides or vaginal lubricants during the month prior to study entry.
  • Very irregular periods or low probability of going at least 18 days without menstruation (short cycles).
  • Have participated in a clinical trial during the month prior to entering the study.
  • Not being able to follow or understand study procedures. This includes not being willing to maintain sexual abstinence during the 24 hours prior to each vaginal sample collection.
  • Any other condition not compatible with the study according to the investigators

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Instituto Hospital del Mar de Investigaciones Médicas

    Barcelona

Other trials in Spain

About this study

Official title: Randomized, Double-blind, Placebo-controlled Study to Evaluate the Vaginal Colonization Capacity, Safety, and Tolerability of Two New Strains of L. Gasseri and L. Crispatus When Administered Orally in Healthy Female Volunteers

Randomized study to determine whether the vaginally isolated strains of Lactobacillus gasseri and/or Lactobacillus crispatus can colonize the vagina when taken orally for 18 days. Secondary outcomes comprise evaluation of safety, tolerability, impact on vaginal microbiota and vaginal pH

Read the detailed description

Double blind, randomized, placebo-controlled biomedical research study to determine whether supplementation with the vaginally isolated strains of Lactobacillus gasseri and/or Lactobacillus crispatus can colonize the vagina. Healthy women who meet inclusion and exclusion criteria will be randomized 1.5:1.5:1 to one of the following study groups: group one will receive L.gasseri for 18 days (1 capsule/day), group two will recieve the combination of L.gasseri and L.Crispatus for 18 days (1 capsule/day) and the other will receive placebo, starting the day after menstruation is over. Main study outcome will be colonization throughout the study, which will be determined by analysis of specific strains by qPCR. Secondary outcomes comprise comprise evaluation of tolerability, impact on vaginal microbiota, vaginal pH and adverse events.

Conditions
Healthy
Being tested
Experimental 1, Experimental 2, Placebo
Keywords
probiotics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental 1Dietary supplement

    Also called Probiotic

    1. gasseri oral capsule once a day (1 x 10^9 CFU/day) for 18 days starting the next day after menstruation is over

  • Experimental 2Dietary supplement

    Also called Probiotic mixture

    1. gasseri and L. crispatus oral capsule once a day (1.5 x 10^9 CFU/day) for 18 days starting the next day after menstruation is over

  • PlaceboDietary supplement

    One maltodextrin-containing capsule a day for 18 days starting the next day after menstruation is over

Study groups in NCT05688397
Study groupRoleWhat they receive
Experimental 1ExperimentalL. gasseri oral capsule
Receives: Dietary Supplement: Experimental 1
Experimental 2ExperimentalL. gasseri + L. crispatus oral capsule
Receives: Dietary Supplement: Experimental 2
PlaceboPlacebo comparatorMaltodextrin (E1400, qs) oral capsule once a day
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Colonization of L. crispatus strain in the vagina

    Change in the concentration of L. crispatus strain throughout study period measured by qPCR in samples obtained with vaginal swab

    Measured: 0,15 or 18 days

  2. Colonization of L. gasseri strain in the vagina

    Change in the concentration of L. gasseri strain throughout study period measured by qPCR in samples obtained with vaginal swab

    Measured: 0,15 or 18 days

Secondary outcomes (9)

  1. Vaginal colonization of L. gasseri strain

    Change in the vaginal concentration of L. gasseri strain measured by qPCR versus baseline

    Measured: Day 0, 3, 6, 9, 12, 15

  2. Vaginal colonization of L. crispatus strain

    Change in the vaginal concentration of L. crispatus strain measured by qPCR versus baseline

    Measured: Day 0, 3, 6, 9, 12, 15

  3. Vaginal microbiota composition

    Change in vaginal microbiota composition measured by 16S rRNA sequencing analysis in samples obtained from vaginal swabs

    Measured: Day 0, 6, 12 and 15 or 18

  4. Perianal concentration of L. crispatus strain

    Change in the perianal concentration of L. crispatus strain measured by qPCR

    Measured: Day 0, 9 and 15 or 18

  5. Perianal concentration of L. gasseri strain

    Change in the perianal concentration of L. gasseri strain measured by qPCR

    Measured: Day 0, 9 and 15 or 18

  6. Vaginal pH

    Change in vaginal pH throughout study period measured by pH test strip

    Measured: Day 0, 3, 6, 9, 12, 15, 18

  7. Gastrointestinal symptoms

    Gastrointestinal manifestations measured on a 4-point scale: 0 = none , 1 = mild, 2 = moderate, and 3 = severe.

    Measured: day 0, day 18

  8. Adverse events

    Frequency of adverse events throughout study period

    Measured: 18 days

  9. Satisfaction with the product

    Evaluation of the satisfaction with the product through the Treatment Satisfaction Questionnaire for Medication (TSQM)

    Measured: Day 18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2023
  2. Study start15 Feb 2023
  3. Primary completion30 Jun 2023
  4. Study completion30 Jun 2023

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05688397
Sponsor's protocol ID
OLIVIA
Status last verified
Jul 2023
First submitted
9 Jan 2023
Last updated
20 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Perez M, Armengol E, Del Casale A, Campedelli I, Aldea-Perona A, Perez Otero M, Rodriguez-Palmero M, Espadaler-Mazo J, Huedo P. Lactobacillus gasseri CECT 30648 shows probiotic characteristics and colonizes the vagina of healthy women after oral administration. Microbiol Spectr. 2025 Sep 2;13(9):e0021125. doi: 10.1128/spectrum.00211-25. Epub 2025 Aug 7.

    PubMed 40772934

Questions about this trial

What is this clinical trial studying?

A study testing Experimental 1 and Experimental 2 in people with Healthy, run by AB Biotics, SA 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 2 inclusion and 15 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 20 Jul 2023. 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. Some participants in this study may receive a placebo. 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?

Colonization of L. crispatus strain in the vagina (time frame: 0,15 or 18 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05688397, which also lists 1 linked publication.

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 20 Jul 2023.

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