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

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

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.

Study Overview

• Status: Completed
• Conditions: Vaginal Infection
• Intervention / Treatment: Dietary supplement: Lactobacillus plantarum

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Cartagena, Spain, 30203
    • Sta María del Rosell university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lactobacillus plantarum; Oral intake 1 cap daily 1E+09 cfu/cap of Lactobacillus plantarum	Dietary supplement: Lactobacillus plantarum; Oral food supplement

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AB Biotics, SA

Publications and helpful links

General Publications

• Reid G, Bruce AW. Urogenital infections in women: can probiotics help? Postgrad Med J. 2003 Aug;79(934):428-32. doi: 10.1136/pmj.79.934.428.
• Guarner F, Schaafsma GJ. Probiotics. Int J Food Microbiol. 1998 Feb 17;39(3):237-8. doi: 10.1016/s0168-1605(97)00136-0. No abstract available.
• Palacios S, Espadaler J, Fernandez-Moya JM, Prieto C, Salas N. Is it possible to prevent recurrent vulvovaginitis? The role of Lactobacillus plantarum I1001 (CECT7504). Eur J Clin Microbiol Infect Dis. 2016 Oct;35(10):1701-8. doi: 10.1007/s10096-016-2715-8. Epub 2016 Jul 9.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2019
• Primary Completion (Actual): February 15, 2020
• Study Completion (Actual): February 15, 2020

Study Registration Dates

• First Submitted: June 2, 2020
• First Submitted That Met QC Criteria: July 7, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Actual): July 8, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: vaginal probiotic
• Other Study ID Numbers: AB-INTIMUS-Colonization

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No