- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05060029
A Pilot Study to Evaluate the Efficacy and Safety of Lactobacillus Species Suppositories on Vaginal Health and pH
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Dr. Shalini Srivastava, MD - Med.
- Phone Number: +91-22-42172300
- Email: shalini.s@vediclifesciences.com
Study Contact Backup
- Name: Dr. Sonali Ghosh, BAMS
- Phone Number: +91-22-42172300
- Email: sonali.g@vediclifesciences.com
Study Locations
-
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Maharashtra
-
Jaipur, Maharashtra, India, 302017
- Recruiting
- JNU Institute for Medical Sciences and Research
-
Contact:
- Dr. Kamlesh Kumari, MS (OBSTETRICS & GYNECOLOGY)
- Phone Number: 7615931030
- Email: clinicalresearch@jnujaipur.ac.in
-
Principal Investigator:
- Dr. Kamlesh Kumari, MS (OBSTETRICS & GYNECOLOGY)
-
Mumbai, Maharashtra, India, 400058
- Not yet recruiting
- Shinde Medicare Hospital
-
Contact:
- Dr. Veena Shinde, MD, DGO
- Phone Number: 9821225392
- Email: drveenashinde@gmail.com
-
Principal Investigator:
- Dr. Veena Shinde, MD, DGO
-
Mumbai, Maharashtra, India, 400064
- Not yet recruiting
- Saraogi Hospital
-
Contact:
- Dr. R.M. Saraogi, MD, DGO
- Phone Number: 9820146689
- Email: drsaraogi@hotmail.com
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Principal Investigator:
- Dr. R.M. Saraogi, MD, DGO
-
Thane, Maharashtra, India, 400605
- Recruiting
- Shreenika Hospital
-
Contact:
- Dr. Shrikant Adsul, MD (Gynaec.)
- Phone Number: 98218 61181
- Email: drshrikantadsul@gmail.com
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Principal Investigator:
- Dr. Shrikant Adsul, MD (Gynaec.)
-
-
Uttar Pradesh
-
Varanasi, Uttar Pradesh, India, 221005
- Recruiting
- Shubham Sudbhawana Superspeciality Hospital,
-
Contact:
- Dr. Pragya Pandey, MBBS MD
- Phone Number: 9696519115
- Email: pragyamadhukar@gmail.com
-
Principal Investigator:
- Dr. Pragya Pandey, MBBS MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Non-pregnant, non-breastfeeding females between the ages of 40 and 65 years, inclusive.
Participants having at least 3 out of following symptoms or signs:
- Homogeneous, thin, white discharge that smoothly coats the vaginal walls.
- Presence of the clue cells on microscopic examination (as assessed by wet mount test)
- pH of vaginal fluid ≥5
- A fishy odor of vaginal discharge.
- Participants with Nugent score of ≥ 7.
- Participants with a total Vaginal Health Index (VHI) score <15.
- Participants with pH ≥ 5.
- Willing to abstain from sexual intercourse 48 hours prior to scheduled clinic visit.
- Participants able to comply with and perform the procedures requested by the protocol (including IP compliance, blood sample collection procedures and study visit schedule).
- Participants who are literate enough to understand the essence of study, are informed about the purpose of the study, and understand their rights.
- Participants able to give written informed consent and willingness to participate in the study and comply with its procedures.
Exclusion Criteria:
- 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).
- Participants who are undergoing Hormone Replacement Therapy (HRT).
- Participants on prebiotics or probiotics in the last 1 month.
- Participants who are currently using antibiotics.
- 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.
- Participants who have undergone total hysterectomy or any other surgery involving the female reproductive system.
- Participants who have been diagnosed with polycystic ovary syndrome (PCOS).
- Uncontrolled type II diabetes mellitus (assessed by RBS ≥140 mg/dL.)
- Use of an immunosuppressive or immunomodulatory drug within 6 months prior to enrolment.
- Participants with uncontrolled hypertension defined as systolic blood pressure (SBP) ≥ 140 mm Hg and/or diastolic blood pressure (DBP) ≥ 90 mm Hg).
- Abnormal Thyroid Stimulating Hormone (TSH) value out of reference range of 0.35 to 5.00 μIU/mL.
- History of any significant neurological and psychiatric condition which may affect the participation and inference of the study's end points.
- Participation in other clinical trials in last 3 months prior to screening.
- Smokers (Past smokers can be allowed if they have abstinence for minimum 2 years).
- Chronic or sporadic abdominal pain including moderate to severe dysmenorrhoea.
Substance abuse problems (within 2 years) defined as:
- Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine dependence.
- 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.
- 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.
- History of hepatitis B/ hepatitis C/ HIV infection.
- Regular medical treatment including over the counter medication, which may have impact on the study aims (e.g., probiotics, antibiotic drugs, laxatives etc.)
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / 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
|
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
|
Coconut Oil Fatty Acids
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 0 to Day 28
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 7 and Day 21
|
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.
|
Day 0, Day 7, Day 21 and Day 28
|
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.
|
Day 0, Day 7, Day 21, and Day 28
|
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.
|
Day 0 and Day 28
|
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.
|
Day 0 and Day 28
|
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
|
Day 7, Day 21, and Day 28
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BP/210503/VB/VDPH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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