Clinical trial NCT03601429: Dietary Supplementation of Lactogyn in Women With Bacterial Vaginosis
Official title: Dietary Supplementation of Lactogyn in Women With Bacterial Vaginosis: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacterial Vaginosis
Lead sponsor: Vesale Pharmaceutica
Sponsor class: INDUSTRY
First posted: 2018-07-26
Enrollment: 166
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion criteria

1. Informed consent form signed;
2. Age: 18-45 years;
3. Able to swallow capsules;
4. Recent symptomatic BV successfully treated with metronidazole tablets in a dose of 500 mg 2 times daily for 7 days;
5. Less than 48 hours after treatment of acute BV defined as three out of four Amsel criteria;
6. Willing to communicate intimate history for the study purposes;
7. Consent not to use spermicides for 4 months after starting TDC;
8. Stated availability throughout the study period and a mobile phone.

Exclusion criteria

1. Post-menopausal;
2. Pregnancy or high risk of;
3. Breast feeding;
4. Currently active STD as determined by history, physical examination, and laboratory tests;
5. Diabetes mellitus;
6. Inflammatory bowel disease;
7. Alcohol or drug addiction as guessed by investigator;
8. Absence of refrigerator;
9. Known moderate to severe disease of any systems;
10. Difficulty to comprehend study requirements as judged by physician;
11. Any erosions, herpes like lesions, cervicitis during vaginal examination;
12. Treatment of BV with other than metronidazole antibiotic;
13. Use of any investigational drug within the previous 30 days;
14. Use of drugs that suppress the immune system.

Primary outcomes:
measure: Percent change in recurrence of BV during Lactogyn supplementation
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lviv
country: Ukraine
facility: Sergiy V. Gerasymov, MD, PhD
Study officials:
affiliation: Vesale Pharma
name: Karl Richir
role: STUDY_DIRECTOR
References: