Dietary Supplementation of Lactogyn in Women With Bacterial Vaginosis
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|ClinicalTrials.gov Identifier: NCT03601429|
Recruitment Status : Completed
First Posted : July 26, 2018
Last Update Posted : April 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Bacterial Vaginosis||Dietary Supplement: Lactogyn Dietary Supplement: Placebo||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||166 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Dietary Supplementation of Lactogyn in Women With Bacterial Vaginosis: a Randomized Clinical Trial|
|Actual Study Start Date :||January 1, 2018|
|Actual Primary Completion Date :||August 31, 2018|
|Actual Study Completion Date :||August 31, 2018|
1 capsule of Lactogyn 2 times daily for the first 7 days then 1 time daily for 4 months
Dietary Supplement: Lactogyn
Placebo Comparator: Placebo
1 capsule of Placebo Comparator 2 times daily for the first 7 days then 1 time daily for 4 months
Dietary Supplement: Placebo
- Percent change in recurrence of BV during Lactogyn supplementation [ Time Frame: 4 months ]Percent change in recurrence of BV during the 4 months of dietary supplementation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03601429
|Sergiy V. Gerasymov, MD, PhD|
|Lviv, Ukraine, 79049|
|Study Director:||Karl Richir||Vesale Pharma|