NCT05688397

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: AB Biotics, SA · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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
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
DIETARY_SUPPLEMENT	Placebo	One maltodextrin-containing capsule a day for 18 days starting the next day after menstruation is over

Timeline

• Start date: 2023-02-15
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2023-01-18
• Last updated: 2023-07-20

Locations

1 site across 1 country: Spain