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Vaginal and Rectal Colonization of Lactobacillus Crispatus NTCVAG04 Following Oral Administration in Patients With History of Vaginitis/Vaginosis

NCT04676503 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-12-21

No results posted yet for this study

Summary

The purpose of this study is to identify the presence of L. Crispatus in the rectum and vagina after oral administration of BIOVAGINIL by searching for specific DNA of the bacterial strain, to evaluate the tolerability of BIOVAGINIL and evaluate the minimum duration of the oral administration necessary to determine the appearance of L. Crispatus.

Conditions

  • Vaginitis
  • Vaginosis

Interventions

DIETARY_SUPPLEMENT

BIOVAGINIL

Biovaginil is a notified food supplement formulated as 480 mg capsules. Each capsule contains Lactobacillus crispatus NTCVAG04 3 billion and Vitamin A 120 μg.

Sponsors & Collaborators

  • NTC srl

    lead INDUSTRY

Principal Investigators

  • Vincenzo De Leo · Ospedale Santa Maria alle Scotte

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-22
Primary Completion
2020-05-27
Completion
2020-07-21

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04676503 on ClinicalTrials.gov