NCT04461782

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
Last Updated

July 8, 2020

Status Verified

June 1, 2020

Enrollment Period

10 months

First QC Date

June 2, 2020

Last Update Submit

July 7, 2020

Conditions

Vaginal Infection

Keywords

vaginal probiotic

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • Lactobacillary grade (LBG) score

    change day 42 from baseline

  • Other bacteria in vagina

    change day 14-23 from baseline

  • Other bacteria in vagina

    change day 42 from baseline

  • Vaginal pH

    Change day 14-23 from baseline

  • Vaginal pH

    Change day 42 from baseline

  • +3 more secondary outcomes

Study Arms (1)

Lactobacillus plantarum

EXPERIMENTAL

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

Dietary Supplement: Lactobacillus plantarum

Interventions

Lactobacillus plantarumDIETARY_SUPPLEMENT

Oral food supplement

Lactobacillus plantarum

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSubjects must be female in order to sample vaginal microbiota
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sta MarĂ­a del Rosell university hospital

Cartagena, 30203, Spain

Location

Related Publications (3)

  • 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.

    PMID: 12954951BACKGROUND

  • 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.

    PMID: 9553803BACKGROUND

  • 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.

    PMID: 27393491BACKGROUND

MeSH Terms

Conditions

Vaginitis

Condition Hierarchy (Ancestors)

Vaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2020

First Posted

July 8, 2020

Study Start

April 15, 2019

Primary Completion

February 15, 2020

Study Completion

February 15, 2020

Last Updated

July 8, 2020

Record last verified: 2020-06

Locations

ES(1)