Dietary Supplementation of Lactogyn in Women With Bacterial Vaginosis

Study Overview
=================
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.

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

Conditions
-----------------
Bacterial Vaginosis

Intervention / Treatment
-----------------
* Dietary Supplement: Lactogyn
* Dietary Supplement: Placebo


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactogyn<br>1 capsule of Lactogyn 2 times daily for the first 7 days then 1 time daily for 4 months | Dietary Supplement: Lactogyn<br>* capsules<br>|
| Placebo Comparator: Placebo<br>1 capsule of Placebo Comparator 2 times daily for the first 7 days then 1 time daily for 4 months | Dietary Supplement: Placebo<br>* capsules<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in recurrence of BV during Lactogyn supplementation | Percent change in recurrence of BV during the 4 months of dietary supplementation | 4 months |