Dietary Supplementation of Lactogyn in Women With Bacterial Vaginosis

NCT03601429 | Completed DMC

• 1 other identifier: BV-SVG-A001
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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

Conditions

Bacterial Vaginosis

Outcome Measures

Primary Outcomes (1)

• Percent change in recurrence of BV during Lactogyn supplementation

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

  4 months

Study Arms (2)

Lactogyn

EXPERIMENTAL

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

Dietary Supplement: Lactogyn

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Lactogyn DIETARY_SUPPLEMENT

capsules

Lactogyn

Placebo DIETARY_SUPPLEMENT

capsules

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vesale Pharmaceutica: lead

Study Sites (1)

Sergiy V. Gerasymov, MD, PhD

Lviv, 79049, Ukraine

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Karl Richir

  Vesale Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2018
• First Posted: July 26, 2018
• Study Start: January 1, 2018
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: April 29, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)