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

NCT04676503 | Completed

• 1 other identifier: NTCVAG04_02-2018
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• Positivity for NTCVAG04 in rectal swabs collected at the end of the first treatment cycle.

  A descriptive statistical analysis will be performed for the rectal swabs for NTCVAG04

  At the end of the first cycle ( the cycle is 14 days - Visit 2 - 21st day (± 2) of the menstrual cycle in progress or following enrolment)

• Positivity for NTCVAG04 in rectal swabs collected at the end of the second treatment cycle.

  A descriptive statistical analysis will be performed for the rectal swabs for NTCVAG04

  At the end of the second treatment cycles (the cycle is 14 days - Visit 3 - 14th day (± 2) of the next menstrual cycle)

• Positivity for NTCVAG04 in vaginal swabs collected at the end of the first treatment cycle.

  A descriptive statistical analysis will be performed for the vaginal swabs for NTCVAG04

  At the end of the first cycle (the cycle is 14 days - Visit 2 - 21st day (± 2) of the menstrual cycle in progress) or following enrolment

• Positivity for NTCVAG04 in vaginal swabs collected at the end of the second treatment cycle.

  A descriptive statistical analysis will be performed for the vaginal swabs for NTCVAG04

  At the end of the second treatment cycles (the cycle is 14 days - Visit 3 - 14th day (± 2) of the next menstrual cycle)

Secondary Outcomes (1)

• Number of patients with adverse events

  up to 30 days

Study Arms (1)

Test Arm - Biovaginil 480 mg capsules

EXPERIMENTAL

All patients will be treated with 1 capsule/day of BIOVAGINIL for two treatment cycles of 14 days each.

Dietary Supplement: BIOVAGINIL

Interventions

BIOVAGINIL DIETARY_SUPPLEMENT

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

Test Arm - Biovaginil 480 mg capsules

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Age \> 18 years
• History of vaginitis/vaginosis
• Informed consent

You may not qualify if:

• Pregnancy
• Breastfeeding
• Need for treatment of vaginitis/vaginosis with any antibiotic drug

Sponsors & Collaborators

• NTC srl: lead

Study Sites (1)

Azienda Ospedaliera Universitaria di Siena - Unità Operativa Semplice Ginecologia Endocrinologica Centro Sterilità di Coppia

Siena, SI, 53100, Italy

Location

MeSH Terms

Conditions

Vaginitis; Vaginal Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Vincenzo De Leo

  Ospedale Santa Maria alle Scotte

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Open-label pilot study

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 21, 2020
• Study Start: November 22, 2019
• Primary Completion: May 27, 2020
• Study Completion: July 21, 2020
• Last Updated: December 21, 2020

Record last verified: 2020-12

Locations

IT (1)