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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-15

Study Completion Date

2020-02-15

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.

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Detailed Description

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Conditions

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Vaginal Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Lactobacillus plantarum

Oral intake 1 cap daily

1E+09 cfu/cap of Lactobacillus plantarum

Group Type EXPERIMENTAL

Lactobacillus plantarum

Intervention Type DIETARY_SUPPLEMENT

Oral food supplement

Interventions

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Lactobacillus plantarum

Oral food supplement

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes