NCT03601429

Dietary Supplementation of Lactogyn in Women With Bacterial Vaginosis

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: Vesale Pharmaceutica · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactogyn	capsules
DIETARY_SUPPLEMENT	Placebo	capsules

Timeline

• Start date: 2018-01-01
• Primary completion: 2018-08-31
• Completion: 2018-08-31
• First posted: 2018-07-26
• Last updated: 2019-04-29

Locations

1 site across 1 country: Ukraine