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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Experimental 1; Dietary Supplement: Experimental 2

• Registration Number: NCT05688397
• Lead Sponsor: AB Biotics, SA

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.

Study Timeline

• Study First Submitted: 2023-01-09
• Study First Submitted QC: 2023-01-09
• Study First Posted: 2023-01-18
• Study Start: 2023-02-15
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-19
• Last Update Posted: 2023-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Maltodextrin (E1400, qs) oral capsule once a day
Experimental 1	Experimental 1	L. gasseri oral capsule
Experimental 2	Experimental 2	L. gasseri + L. crispatus oral capsule

Primary Outcome Measures

Name	Time	Method
Colonization of L. crispatus strain in the vagina	0,15 or 18 days	Change in the concentration of L. crispatus strain throughout study period measured by qPCR in samples obtained with vaginal swab
Colonization of L. gasseri strain in the vagina	0,15 or 18 days	Change in the concentration of L. gasseri strain throughout study period measured by qPCR in samples obtained with vaginal swab

Secondary Outcome Measures

Name	Time	Method
Vaginal microbiota composition	Day 0, 6, 12 and 15 or 18	Change in vaginal microbiota composition measured by 16S rRNA sequencing analysis in samples obtained from vaginal swabs
Gastrointestinal symptoms	day 0, day 18	Gastrointestinal manifestations measured on a 4-point scale: 0 = none , 1 = mild, 2 = moderate, and 3 = severe.
Vaginal colonization of L. crispatus strain	Day 0, 3, 6, 9, 12, 15	Change in the vaginal concentration of L. crispatus strain measured by qPCR versus baseline
Vaginal colonization of L. gasseri strain	Day 0, 3, 6, 9, 12, 15	Change in the vaginal concentration of L. gasseri strain measured by qPCR versus baseline
Perianal concentration of L. gasseri strain	Day 0, 9 and 15 or 18	Change in the perianal concentration of L. gasseri strain measured by qPCR
Adverse events	18 days	Frequency of adverse events throughout study period
Perianal concentration of L. crispatus strain	Day 0, 9 and 15 or 18	Change in the perianal concentration of L. crispatus strain measured by qPCR
Satisfaction with the product	Day 18	Evaluation of the satisfaction with the product through the Treatment Satisfaction Questionnaire for Medication (TSQM)
Vaginal pH	Day 0, 3, 6, 9, 12, 15, 18	Change in vaginal pH throughout study period measured by pH test strip

Trial Locations

Locations (1)

Instituto Hospital del Mar de Investigaciones Médicas; 🇪🇸 Barcelona, Spain