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Dietary Supplementation of Lactogyn in Women With Bacterial Vaginosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03601429
Recruitment Status : Completed
First Posted : July 26, 2018
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Bacterial Vaginosis Dietary Supplement: Lactogyn Dietary Supplement: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lactogyn
1 capsule of Lactogyn 2 times daily for the first 7 days then 1 time daily for 4 months
Dietary Supplement: Lactogyn
capsules

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
capsules




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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Ukraine
Sergiy V. Gerasymov, MD, PhD
Lviv, Ukraine, 79049
Sponsors and Collaborators
Vesale Pharmaceutica
Investigators
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Study Director: Karl Richir Vesale Pharma

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Responsible Party: Vesale Pharmaceutica
ClinicalTrials.gov Identifier: NCT03601429     History of Changes
Other Study ID Numbers: BV-SVG-A001
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Vaginal Diseases
Vaginosis, Bacterial
Genital Diseases, Female
Bacterial Infections
Vaginitis