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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Experimental 1
* Dietary Supplement: Experimental 2
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental 1<br>L. gasseri oral capsule | Dietary Supplement: Experimental 1<br>* L. gasseri oral capsule once a day (1 x 10^9 CFU/day) for 18 days starting the next day after menstruation is over<br>* Other names: Probiotic;|
| Experimental: Experimental 2<br>L. gasseri + L. crispatus oral capsule | Dietary Supplement: Experimental 2<br>* 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<br>* Other names: Probiotic mixture;|
| Placebo Comparator: Placebo<br>Maltodextrin (E1400, qs) oral capsule once a day | Dietary Supplement: Placebo<br>* One maltodextrin-containing capsule a day for 18 days starting the next day after menstruation is over<br>|

What is the study measuring?
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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 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 | 
| 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 | 
| 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 | 
| Vaginal pH | Change in vaginal pH throughout study period measured by pH test strip | Day 0, 3, 6, 9, 12, 15, 18 | 
| Gastrointestinal symptoms | Gastrointestinal manifestations measured on a 4-point scale: 0 = none , 1 = mild, 2 = moderate, and 3 = severe. | day 0, day 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotics