Interventional Study to Evaluate the Effect of the Oral Administration of L.Plantarum on Vaginal Microbiota

Study Overview
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Brief Summary
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Vaginal microbiota is abundantly colonized by Lactobacillus genera. When vaginal microbiota gets altered, opportunistic microorganisms may proliferate and become abundant species giving rise to dysbiosis. Probiotics are living organisms that provide the host certain benefits. Despite probiotics have been historically linked to intestinal microbiota, several research groups have published positive results for some Lactobacillus strains in vaginal microbiota. The Lactobacillus strain investigated in the presented project showed the ability to prevent recurrent vaginal Candidiasis in women with high vaginal candidiasis prevalence. Nowadays the Lactobacillus strain here investigated is commercialized as vaginal caps, however oral intake is widely preferred among consumers. Because of that, this study aims to determine whether this Lactobacillus strain is able to colonize vaginal microbiota when administered orally.

Official Title
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Interventional Study to Evaluate the Effect of a Food Supplement Comprising L. Plantarum After Oral Intake in Vaginal Microbiota

Conditions
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Vaginal Infection

Intervention / Treatment
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* Dietary Supplement: Lactobacillus plantarum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Asymptomatic subjects with vaginal microbiota classified as LBG (Lactobacillary grade) I, IIa or IIb. Using the same contraceptive within 4 weeks prior to study start. Exclusion Criteria: Current vaginal infection. Vaginal infection 1 month prior to study start. Cervico-vaginal pathology. Papilloma human virus. Pregnant or breastfeeding mothers. Using IUD. Immunomodulators or systemic corticoids intake. Vaginal or systemic antibiotics intake 1 month prior to study start. Vaginal probiotic intake 1 month prior to study start. Less than three months after giving birth or abortion. Undergone vaginal or intestinal surgery three months prior to study start. Severe stress or depression. Systemic acute or severe disease. History of alcohol or drug abuse. Chronic intestinal pathology. Not understanding protocol procedures. Use of lubricant 24 hours or spermicide 7 days prior to study start. Swallowing difficulties. Impossibility to understand study procedures. Enrolled in another clinical study. Atrophic vaginitis not under treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactobacillus plantarum<br>Oral intake 1 cap daily 1E+09 cfu/cap of Lactobacillus plantarum | Dietary Supplement: Lactobacillus plantarum<br>* Oral food supplement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colonization | Determine the relative presence of Lactobacillus plantarum in vaginal microbiota by metagenomic analysis | change day 14-23 from baseline | 
| Colonization | Determine the relative presence of Lactobacillus plantarum in vaginal microbiota by metagenomic analysis | change day 42 from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lactobacillary grade (LBG) score | obtained by cytology analysis by pathologists and calculated according to Donders et al., 2002. Higher scores imply more severe conditions. Scale ranges from 1 to 3. | change day 42 from baseline | 
| Other bacteria in vagina | Detection of other bacteria by metagenomic analysis | change day 14-23 from baseline | 
| Other bacteria in vagina | Detection of other bacteria by metagenomic analysis | change day 42 from baseline | 
| Vaginal pH | Measured through urine test strip | Change day 14-23 from baseline | 
| Vaginal pH | Measured through urine test strip | Change day 42 from baseline | 
| Product satisfaction | Measured with a categorical scale (Likert type) going from 0 to 5 . Where 0 is very insatisfied and 5 is very satisfied | day 14-23 | 
| Safety and tolerability | Analyzed by the number of adverse events registered during the study | through study completion, an average of 42 days | 
| Gastrointestinal symptoms | Analyzed by the validated Spanish translation of Gastrointestinal Symptom Rating Scale (GSRS) according to Kulich et al., 2005. Score ranges from 0 to 90 where 0 is no symptoms at all and 90 is the highest severity in all symptoms assessed (e.g. pain, bloating, etc) | Change day 14-23 from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaginal probiotic