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A Pilot Study to Evaluate the Efficacy and Safety of Lactobacillus Species Suppositories on Vaginal Health and pH

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ClinicalTrials.gov Identifier: NCT05060029
Recruitment Status : Not yet recruiting
First Posted : September 28, 2021
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
Vedic Lifesciences Pvt. Ltd.

Brief Summary:
Most of the methods involved in the treatment of BV include antibiotics. Some of the antibiotics used for this include metronidazole, clindamycin and fluconazole. The antibiotics inhibit the growth of anaerobes that support G. vaginalis and other microbes without affecting lactobacilli. This leads to the treatment of BV while also preventing its recurrence. However, the use of antibiotics may lead to antibiotic resistance and cause various side-effects such as thrush, dizziness, rash, nausea, etc. In the case of many antibiotics, the cure rates were incredibly poor and the BV recurrence rates reached as high as 80 %. Probiotic therapy has slowly been replacing antibiotics for the treatment and prevention of BV and other infections. These probiotics usually contain lactobacilli and help maintain a healthy vaginal environment. They can either be consumed through curd and other milk products that contain probiotics (mostly lactobacilli) or they can be used in the form of suppositories that are placed in the vagina. In probiotics containing lactobacilli, the lactic acid produced by the bacteria lowers the vaginal pH to the ideal range of 3.5 to 4.5 and prevents infection recurrence. Lactobacilli containing suppositories have been successfully used in the past to treat BV, being marketed as a safe and effective way to prevent and treat infections for women in various stages of their lives.

Condition or disease Intervention/treatment Phase
Bacterial Vaginosis Drug: Lactobacillus Species Other: Placebo Phase 4

Detailed Description:

The vaginal microbiome is said to be the first line of defence against vaginal infection, due to competitive exclusion and the destruction of pathogenic microbes. The vagina remains relatively sterile until a woman reaches puberty, after which the hormonal changes cause the colonization of lactobacilli in the vaginal environment. Any alterations in the microbiota are seen to cause symptomatic conditions. These conditions may include bacterial vaginosis (BV), vaginal candidiasis and trichomoniasis. The reduction in circulating hormone levels in older women as they near menopause triggers various physiological changes in the vagina. Vulvovaginal atrophy, dryness, itchiness, redness, loss of elasticity, inflammation and atypical secretions are some of the changes that occur in the vagina as estrogen and progesterone levels decrease in the blood.

The aforementioned reduction in hormone levels would also lead to a decline in the concentration of lactobacilli in the vaginal environment. The lactobacilli produce lactic acid, which creates an acidic vaginal environment conducive to the growth of lactobacilli, while preventing the growth of other anaerobic bacterial species. The dominant lactobacilli also prevent the binding of other bacteria to the epithelial cells and the lactic acid produced by lactobacilli blocks histone deacetylases, thereby enhancing gene transcription and DNA repair within their cells. Moreover, the lactobacilli also inhibit the induction of pro-inflammatory cytokines while promoting homeostasis. Some of the species from the Lactobacilli genus that have been identified as residents of the vaginal environment include L. crispatus, L. gasseri, L. iners, and L. jensenii Therefore, it is seen that women who experience lowering of hormone levels i.e. as they approach menopause, the chances of contracting vaginal infection increases due to the lower concentrations of lactobacilli. Bacteria such as Gardnerella, Atopobium, Mobiluncus, Prevotella, Streptococcus, Ureaplasma and Megasphaera, which were previously left dormant due to the lactobacilli, may increase in concentration and increase the susceptibility of these women to contract infections such as bacterial vaginosis.

Bacterial vaginosis is usually caused by the overabundance of G. vaginalis and other anaerobes, and can be clinically diagnosed using the Amsel criteria. This technique requires at least three positive findings of the four diagnostic criteria: a fishy odor after a 10% potassium hydroxide test for vaginal secretion, the presence of non-inflammatory vaginal discharge, clue cells on microscopic examination, and vaginal fluid pH > 4.5. The nugent score is also a well-validated technique to diagnose BV.

In this study, the safety and efficacy of the vaginal suppository VagiBIOM will be studied in aging women with BV infection. The effect of the suppository on vaginal pH and the physiological changes in the vagina will be examined, along with its impact on vaginal infection.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blinded, placebo-controlled study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: In order to preserve the blinding, IP and placebo suppositories will be matched for size, shape, color, and texture. They will be packed in identical fashion in terms of size, color, as well as labelling. The blinding will be done at the CRO (Vedic Lifesciences Pvt. Ltd.). The participant IDs will be arranged in chronological order as per the randomization chart. This chart will be secured, saved and maintained in the electronic Trial Master File (TMF) under the respective project folder.
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate the Efficacy and Safety of Lactobacillus Species Suppositories on Vaginal Health and pH
Estimated Study Start Date : September 25, 2021
Estimated Primary Completion Date : July 12, 2022
Estimated Study Completion Date : July 12, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lactobacillus Species Suppositories
Coconut oil fatty acids, hyaluronic acid, patented VagiBIOM Probiotic complex CFU (Lactobacillus crispatus Bi16, Lactobacillus gasseri Bi19, Bacillus coagulans Bi34, Lactobacillus acidophilus Bi14) hydrolyzed cellulose, oligofructose, silica gel, lactic acid
Drug: Lactobacillus Species
Lactobacilli containing suppositories have been successfully used in the past to maintain the vaginal environment and for treatment of infections like BV. Some of the Lactobacilli species that have been used include Lactobacillus acidophilus, Lactobacillus crispatus, Lactobacillus gasseri and Lactobacillus plantarum, none of which demonstrated any safety concerns. The investigational product, which contains a Lactobacilli complex as its main component, has already been marketed as a tool to maintain vaginal microbial balance, pH and the prevention of microbial infection, thus there are no additional safety concerns or risks involved in this clinical trial design.

Placebo Comparator: Coconut Oil Suppositories
Coconut oil fatty acid suppositories
Other: Placebo
Coconut Oil Fatty Acids
Other Name: Coconut Oil




Primary Outcome Measures :
  1. Evaluate the efficacy of IP on Vaginal pH [ Time Frame: Day 0 to Day 28 ]
    To evaluate the efficacy of Investigational product (IP) on Vaginal pH as assessed by a pH indicator from baseline to Day 28 in comparison to placebo.


Secondary Outcome Measures :
  1. Evaluate the efficacy of IP on Vaginal pH [ Time Frame: Day 7 and Day 21 ]
    Vaginal pH as assessed by a pH indicator from baseline to Day 7 and Day 21 in comparison to placebo.

  2. Evaluate the efficacy of IP on Vaginal Itching [ Time Frame: Day 0, Day 7, Day 21 and Day 28 ]
    Vaginal itching as assessed by Visual Analogue Scale (0-10) from baseline to Day 28 in comparison to placebo.

  3. Evaluate the efficacy on Microbial Infection control [ Time Frame: Day 0, Day 7, Day 21, and Day 28 ]
    Microbial infection control as assessed by the Nugent score from baseline to Day 28 in comparison to placebo.

  4. Evaluate the efficacy as per Vaginal Health Index [ Time Frame: Day 0 and Day 28 ]
    Overall Vaginal Health as assessed through clinical examination using the Vaginal Health Index from baseline to Day 28 in comparison to placebo.

  5. Efficacy as per percentage responders in Nugent Score. [ Time Frame: Day 0 and Day 28 ]
    Percentage responders as assessed by the number of BV-free women determined using the Nugent score at Day 28 in comparison to placebo.

  6. To evaluate the total number of Adverse Events [ Time Frame: Day 7, Day 21, and Day 28 ]
    Number of participants who experienced adverse events from baseline in comparison to placebo



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Non-pregnant, non-breastfeeding females between the ages of 40 and 65 years, inclusive.
  2. Participants having at least 3 out of following symptoms or signs:

    1. Homogeneous, thin, white discharge that smoothly coats the vaginal walls.
    2. Presence of the clue cells on microscopic examination (as assessed by wet mount test)
    3. pH of vaginal fluid ≥5
    4. A fishy odor of vaginal discharge.
  3. Participants with Nugent score of ≥ 7.
  4. Participants with a total Vaginal Health Index (VHI) score <15.
  5. Participants with pH ≥ 5.
  6. Willing to abstain from sexual intercourse 48 hours prior to scheduled clinic visit.
  7. Participants able to comply with and perform the procedures requested by the protocol (including IP compliance, blood sample collection procedures and study visit schedule).
  8. Participants who are literate enough to understand the essence of study, are informed about the purpose of the study, and understand their rights.
  9. Participants able to give written informed consent and willingness to participate in the study and comply with its procedures.

Exclusion Criteria:

  1. Participants with signs or symptoms of vaginal or cervical or pelvic or urinary infection on screening or clinical diagnosis of vaginal/cervical/pelvic/ urinary infection in the past 14 days (including but not limited to yeast vulvovaginitis, chlamydia, gonorrhea, trichomonas, genital ulcer disease, pelvic inflammatory disease).
  2. Participants who are undergoing Hormone Replacement Therapy (HRT).
  3. Participants on prebiotics or probiotics in the last 1 month.
  4. Participants who are currently using antibiotics.
  5. Participants with history/ signs of cervical or vaginal high grade squamous intraepithelial dysplasia (HSIL), atypical glandular cells of uncertain significance (AGUS) or cervical intraepithelial neoplasia.
  6. Participants who have undergone total hysterectomy or any other surgery involving the female reproductive system.
  7. Participants who have been diagnosed with polycystic ovary syndrome (PCOS).
  8. Uncontrolled type II diabetes mellitus (assessed by RBS ≥140 mg/dL.)
  9. Use of an immunosuppressive or immunomodulatory drug within 6 months prior to enrolment.
  10. Participants with uncontrolled hypertension defined as systolic blood pressure (SBP) ≥ 140 mm Hg and/or diastolic blood pressure (DBP) ≥ 90 mm Hg).
  11. Abnormal Thyroid Stimulating Hormone (TSH) value out of reference range of 0.35 to 5.00 μIU/mL.
  12. History of any significant neurological and psychiatric condition which may affect the participation and inference of the study's end points.
  13. Participation in other clinical trials in last 3 months prior to screening.
  14. Smokers (Past smokers can be allowed if they have abstinence for minimum 2 years).
  15. Chronic or sporadic abdominal pain including moderate to severe dysmenorrhoea.
  16. Substance abuse problems (within 2 years) defined as:

    1. Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine dependence.
    2. High-risk drinking as defined by consumption of 4 or more alcohol containing beverages on any day or 8 or more alcohol containing beverages per week for women.
  17. Any of the following clinically significant illness, i.e. Cardiovascular, endocrine system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, neuropsychiatric, musculoskeletal, inflammatory, blood and tumors, gastrointestinal diseases, etc.
  18. History of hepatitis B/ hepatitis C/ HIV infection.
  19. Regular medical treatment including over the counter medication, which may have impact on the study aims (e.g., probiotics, antibiotic drugs, laxatives etc.)
  20. Any condition that could, in the opinion of the investigator, preclude the participant's ability to successfully and safely complete the study or that may confound study outcomes.

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): NCT05060029


Contacts
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Contact: Dr. Shalini Srivastava, MD - Med. +91-22-42172300 shalini.s@vediclifesciences.com
Contact: Mr. Harshdeep Asrodia, B.Pharm. +91-22-42172300 harshdeep.a@vediclifesciences.com

Locations
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India
Shinde Medicare Hospital
Mumbai, Maharashtra, India, 400058
Contact: Dr. Veena Shinde, MD, DGO    9821225392    drveenashinde@gmail.com   
Principal Investigator: Dr. Veena Shinde, MD, DGO         
Saraogi Hospital
Mumbai, Maharashtra, India, 400064
Contact: Dr. R.M. Saraogi, MD, DGO    9820146689    drsaraogi@hotmail.com   
Principal Investigator: Dr. R.M. Saraogi, MD, DGO         
Shreenika Hospital
Thane, Maharashtra, India, 400605
Contact: Dr. Shrikant Adsul, MD (Gynaec.)    98218 61181    drshrikantadsul@gmail.com   
Principal Investigator: Dr. Shrikant Adsul, MD (Gynaec.)         
Sponsors and Collaborators
Vedic Lifesciences Pvt. Ltd.
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Responsible Party: Vedic Lifesciences Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT05060029    
Other Study ID Numbers: BP/210503/VB/VDPH
First Posted: September 28, 2021    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Vaginosis, Bacterial
Vaginal Diseases
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Vaginitis