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

AB Biotics

Status: Completed

Conditions: Vaginal Infection

Treatments: Dietary Supplement: Lactobacillus plantarum

Study type: Interventional

Funder types: Industry

Identifiers

NCT04461782

AB-INTIMUS-Colonization

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Lactobacillus plantarum

Experimental group

Description:

Oral intake 1 cap daily 1E+09 cfu/cap of Lactobacillus plantarum

Treatment:

Dietary Supplement: Lactobacillus plantarum