Dietary Supplementation of Lactogyn in Women With Bacterial Vaginosis

Not Applicable

Completed

• Conditions: Bacterial Vaginosis
• Interventions: Dietary Supplement: Lactogyn; Dietary Supplement: Placebo

• Registration Number: NCT03601429
• Lead Sponsor: Vesale Pharmaceutica

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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-07-04
• Study First Submitted QC: 2018-07-17
• Study First Posted: 2018-07-26
• Primary Completion: 2018-08-31
• Study Completion: 2018-08-31
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-25
• Last Update Posted: 2019-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 166

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percent change in recurrence of BV during Lactogyn supplementation	4 months	Percent change in recurrence of BV during the 4 months of dietary supplementation

Trial Locations

Locations (1)

Sergiy V. Gerasymov, MD, PhD; 🇺🇦 Lviv, Ukraine