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Dietary Supplementation of Lactogyn in Women With Bacterial Vaginosis

Primary Purpose

Bacterial Vaginosis

Status

Completed

Phase

Not Applicable

Locations

Ukraine

Study Type

Interventional

Intervention

Lactogyn

Placebo

About this trial

This is an interventional prevention trial for Bacterial Vaginosis

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion criteria

Informed consent form signed;
Age: 18-45 years;
Able to swallow capsules;
Recent symptomatic BV successfully treated with metronidazole tablets in a dose of 500 mg 2 times daily for 7 days;
Less than 48 hours after treatment of acute BV defined as three out of four Amsel criteria;
Willing to communicate intimate history for the study purposes;
Consent not to use spermicides for 4 months after starting TDC;
Stated availability throughout the study period and a mobile phone.

Exclusion criteria

Post-menopausal;
Pregnancy or high risk of;
Breast feeding;
Currently active STD as determined by history, physical examination, and laboratory tests;
Diabetes mellitus;
Inflammatory bowel disease;
Alcohol or drug addiction as guessed by investigator;
Absence of refrigerator;
Known moderate to severe disease of any systems;
Difficulty to comprehend study requirements as judged by physician;
Any erosions, herpes like lesions, cervicitis during vaginal examination;
Treatment of BV with other than metronidazole antibiotic;
Use of any investigational drug within the previous 30 days;
Use of drugs that suppress the immune system.

Sites / Locations

Sergiy V. Gerasymov, MD, PhD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lactogyn

Placebo

Arm Description

1 capsule of Lactogyn 2 times daily for the first 7 days then 1 time daily for 4 months

1 capsule of Placebo Comparator 2 times daily for the first 7 days then 1 time daily for 4 months

Outcomes

Primary Outcome Measures

Percent change in recurrence of BV during Lactogyn supplementation

Percent change in recurrence of BV during the 4 months of dietary supplementation

Secondary Outcome Measures

Full Information

NCT ID

NCT03601429

First Posted

July 4, 2018

Last Updated

April 25, 2019

Sponsor

Vesale Pharmaceutica

1. Study Identification

Unique Protocol Identification Number

NCT03601429

Brief Title

Dietary Supplementation of Lactogyn in Women With Bacterial Vaginosis

Official Title

Dietary Supplementation of Lactogyn in Women With Bacterial Vaginosis: a Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

January 1, 2018 (Actual)

Primary Completion Date

August 31, 2018 (Actual)

Study Completion Date

August 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vesale Pharmaceutica

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The objective of the study is to determine clinical efficacy of Lactogyn (Lactobacillus Crispatus, L. brevis, L.acidophilus) in prevention of recurrent BV

Detailed Description

According to classification, this is a phase 2 randomized parallel group prospective controlled dietary study to evaluate efficacy of a dietary supplement, a combination of L. crispatus LMG S-29995, L. brevis, and L. acidophilus in women aged from 18 through 45 years suffering from rBV. The 2 phase of the study has been ascribed as there is no evidence that oral capsules with L. crispatus LMG S-29995, L. brevis, and L. acidophilus have a potential efficacy in rBV. Qualifying women received a combination of the three probiotic strains with a half daily recommended dose of vitamin C or just vitamin C without probiotics, a control supplementation, via oral route of administration for up to 120 days. During the intake of active or control formulations, participants kept a structured 120-DSD, where they recorded test capsules intake, screen for symptoms of bacterial vaginosis, and food intolerance events. Based on repeat physical examination with application of Amsel and Nugent criteria the main conclusions over the efficacy of probiotic strains were made.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bacterial Vaginosis

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

166 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lactogyn

Arm Type

Experimental

Arm Description

1 capsule of Lactogyn 2 times daily for the first 7 days then 1 time daily for 4 months

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

1 capsule of Placebo Comparator 2 times daily for the first 7 days then 1 time daily for 4 months

Intervention Type

Dietary Supplement

Intervention Name(s)

Lactogyn

Intervention Description

capsules

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

capsules

Primary Outcome Measure Information:

Title

Percent change in recurrence of BV during Lactogyn supplementation

Description

Percent change in recurrence of BV during the 4 months of dietary supplementation

Time Frame

4 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria Informed consent form signed; Age: 18-45 years; Able to swallow capsules; Recent symptomatic BV successfully treated with metronidazole tablets in a dose of 500 mg 2 times daily for 7 days; Less than 48 hours after treatment of acute BV defined as three out of four Amsel criteria; Willing to communicate intimate history for the study purposes; Consent not to use spermicides for 4 months after starting TDC; Stated availability throughout the study period and a mobile phone. Exclusion criteria Post-menopausal; Pregnancy or high risk of; Breast feeding; Currently active STD as determined by history, physical examination, and laboratory tests; Diabetes mellitus; Inflammatory bowel disease; Alcohol or drug addiction as guessed by investigator; Absence of refrigerator; Known moderate to severe disease of any systems; Difficulty to comprehend study requirements as judged by physician; Any erosions, herpes like lesions, cervicitis during vaginal examination; Treatment of BV with other than metronidazole antibiotic; Use of any investigational drug within the previous 30 days; Use of drugs that suppress the immune system.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karl Richir

Organizational Affiliation

Vesale Pharma

Official's Role

Study Director

Facility Information:

Facility Name

Sergiy V. Gerasymov, MD, PhD

City

Lviv

ZIP/Postal Code

79049

Country

Ukraine

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Dietary Supplementation of Lactogyn in Women With Bacterial Vaginosis

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