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

NCT ID: NCT05688397

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-15
• Study Completion Date: 2023-06-30

Brief 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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental 1

L. gasseri oral capsule

Group Type: EXPERIMENTAL

Experimental 1

Intervention Type: DIETARY_SUPPLEMENT

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

Experimental 2

L. gasseri + L. crispatus oral capsule

Group Type: EXPERIMENTAL

Experimental 2

Intervention Type: DIETARY_SUPPLEMENT

L. 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

Placebo

Maltodextrin (E1400, qs) oral capsule once a day

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Experimental 1

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

Intervention Type: DIETARY_SUPPLEMENT

Experimental 2

L. 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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Probiotic; Probiotic mixture

Eligibility Criteria

Inclusion Criteria

• Healthy women
• Reproductive age 18-45 years

Exclusion Criteria

• 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.
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

AB Biotics, SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ana Maria Aldea Perona, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto Hospital del Mar de Investigaciones Médicas

Locations

Instituto Hospital del Mar de Investigaciones Médicas

Barcelona, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 40772934 (View on PubMed)

Other Identifiers

OLIVIA

Identifier Type: -

Identifier Source: org_study_id