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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Experimental 1; Dietary supplement: Experimental 2

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Instituto Hospital del Mar de Investigaciones Médicas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Maltodextrin (E1400, qs) oral capsule once a day	Dietary supplement: Placebo; One maltodextrin-containing capsule a day for 18 days starting the next day after menstruation is over
Experimental: Experimental 1; L. gasseri oral capsule	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; Other Names: Probiotic
Experimental: Experimental 2; L. gasseri + L. crispatus oral capsule	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; Other Names: Probiotic mixture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	0,15 or 18 days
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	0,15 or 18 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: AB Biotics, SA
• Investigators: Principal Investigator: Ana Maria Aldea Perona, PhD, Instituto Hospital del Mar de Investigaciones Médicas

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: January 9, 2023
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: probiotics
• Other Study ID Numbers: OLIVIA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No