Dietary Supplementation of Lactogyn in Women With Bacterial Vaginosis

NCT ID: NCT03601429

Last Updated: 2019-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2018-08-31

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.

Conditions

Bacterial Vaginosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Lactogyn

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

Group Type: EXPERIMENTAL

Lactogyn

Intervention Type: DIETARY_SUPPLEMENT

capsules

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

capsules

Interventions

Lactogyn

capsules

Intervention Type: DIETARY_SUPPLEMENT

Placebo

capsules

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Informed consent form signed;

2. Age: 18-45 years;

3. Able to swallow capsules;

4. Recent symptomatic BV successfully treated with metronidazole tablets in a dose of 500 mg 2 times daily for 7 days;

5. Less than 48 hours after treatment of acute BV defined as three out of four Amsel criteria;

6. Willing to communicate intimate history for the study purposes;

7. Consent not to use spermicides for 4 months after starting TDC;

8. Stated availability throughout the study period and a mobile phone.

Exclusion Criteria

1. Post-menopausal;

2. Pregnancy or high risk of;

3. Breast feeding;

4. Currently active STD as determined by history, physical examination, and laboratory tests;

5. Diabetes mellitus;

6. Inflammatory bowel disease;

7. Alcohol or drug addiction as guessed by investigator;

8. Absence of refrigerator;

9. Known moderate to severe disease of any systems;

10. Difficulty to comprehend study requirements as judged by physician;

11. Any erosions, herpes like lesions, cervicitis during vaginal examination;

12. Treatment of BV with other than metronidazole antibiotic;

13. Use of any investigational drug within the previous 30 days;

14. Use of drugs that suppress the immune system.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Vesale Pharmaceutica

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karl Richir

Role: STUDY_DIRECTOR

Vesale Pharma

Locations

Sergiy V. Gerasymov, MD, PhD

Lviv, , Ukraine

Countries

Ukraine

Other Identifiers

BV-SVG-A001

Identifier Type: -

Identifier Source: org_study_id