A Pilot Study to Evaluate the Efficacy and Safety of Lactobacillus Species Suppositories on Vaginal Health and pH
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05060029|
Recruitment Status : Not yet recruiting
First Posted : September 28, 2021
Last Update Posted : September 28, 2021
|Condition or disease||Intervention/treatment||Phase|
|Bacterial Vaginosis||Drug: Lactobacillus Species Other: Placebo||Phase 4|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|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.|
|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|
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
Coconut Oil Fatty Acids
Other Name: Coconut Oil
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
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
|Contact: Dr. Shalini Srivastava, MD - Med.||+firstname.lastname@example.org|
|Contact: Mr. Harshdeep Asrodia, B.Pharm.||+email@example.com|
|Shinde Medicare Hospital|
|Mumbai, Maharashtra, India, 400058|
|Contact: Dr. Veena Shinde, MD, DGO 9821225392 firstname.lastname@example.org|
|Principal Investigator: Dr. Veena Shinde, MD, DGO|
|Mumbai, Maharashtra, India, 400064|
|Contact: Dr. R.M. Saraogi, MD, DGO 9820146689 email@example.com|
|Principal Investigator: Dr. R.M. Saraogi, MD, DGO|
|Thane, Maharashtra, India, 400605|
|Contact: Dr. Shrikant Adsul, MD (Gynaec.) 98218 61181 firstname.lastname@example.org|
|Principal Investigator: Dr. Shrikant Adsul, MD (Gynaec.)|