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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05688397
• Other study ID #: OLIVIA
• Status: Completed
• Phase: N/A
• Start date: February 15, 2023
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2023
• Source: AB Biotics, SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Spain	Instituto Hospital del Mar de Investigaciones Médicas	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
AB Biotics, SA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Vaginal pH	Change in vaginal pH throughout study period measured by pH test strip	Day 0, 3, 6, 9, 12, 15, 18
Secondary	Gastrointestinal symptoms	Gastrointestinal manifestations measured on a 4-point scale: 0 = none , 1 = mild, 2 = moderate, and 3 = severe.	day 0, day 18
Secondary	Adverse events	Frequency of adverse events throughout study period	18 days
Secondary	Satisfaction with the product	Evaluation of the satisfaction with the product through the Treatment Satisfaction Questionnaire for Medication (TSQM)	Day 18