An interventional study of 0.9% NaCl physiological saline and LiveSpo X-secret in Vaginitis, sponsored by Anabio R&D. Completed at 2 sites in Vietnam. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-07-25.
Sponsored by Anabio R&D · Not applicable, Interventional, and Treatment
Vaginitis is a common reproductive infection in women worldwide, particularly in tropical and underdeveloped countries. Traditional antibiotic treatments can disrupt the balance of beneficial bacteria, requiring repeated use, seriously affecting women's health. Therefore, probiotics are microorganisms that are beneficial to human health when consumed in sufficient amounts, playing an important role in maintaining the balance of the body's microflora, especially in the intestines and vagina. Many studies around the world have proven that probiotic strains belonging to the genera Lactobacillus, Bifidobacterium, Bacillus, and Saccharomyces can help reduce the incidence and severity of bacterial vaginal infections and yeast infections. However, the effectiveness of oral or tablet probiotics is limited due to a slow onset of action and sensitivity to acidic conditions and temperature. In this study, the investigators proposed that vaginal spray probiotics containing Bacillus strains combined with proven stability in both acidic and thermal environments, may be a safe and effective symptomatic treatment for vaginal infections due to pathogenic bacteria, viruses, fungi, and/or flagellates. This probiotic supportive therapy may offer a promising alternative to traditional antibiotic therapy by (i) inhibiting the growth of pathogenic microorganism; (ii) regulating pro-inflammatory cytokines; and (iii) improving vaginal microbiota.
The aim of the study is to evaluate the effectiveness of vaginal-spraying Bacillus probiotics in LiveSpo®️ X-SECRET (5 billion CFU/5 mL B. subtilis, B. clausii, and B. coagulans) in preventing and supporting the treatment of vaginal infections.
Study Population: The study is being carried out at Hanoi Obstetrics and Gynecology Hospital (Hanoi OGH) and Bac Ninh Center for Disease Control and Prevention (Bac Ninh CDC). The sample size is 120 per each location.
Description of Study Intervention: In each location, a total of 120 eligible patients are recruited and divided randomly into 2 groups (n = 60/group/location): Control and Experimental groups. Patients in the Control group received routine treatment and 2-3 times/day 0.9% NaCl physiological saline while patients in the experimental group were treated with LiveSpo X-SECRET 2-3 times/day in addition to the same standard of care treatment. While the standard treatment regimen lasts for 7 days, the probiotic treatment is continually maintained for 28 days.
Study duration: 8 months.
Vaginitis is a disease related to women's reproductive tract including bacterial vaginosis (Bacterial vaginosis - BV), sexually transmitted diseases (Sexually Transmitted Diseases - STDs)... This is considered is a common infection in the world, especially in developing and underdeveloped tropical countries, with up to 3/4 of the population suffering from STDs, mainly in the reproductive age group of 15-24. There are many microbial agents that cause gynecological diseases, including bacteria, viruses, fungi, flagellates... Bacterial vaginosis is an endogenous vaginal infection caused by more than 30 different species of bacteria, mainly mainly anaerobic bacteria such as Gardnerella vaginalis, Mycoplasma hominis, M. genitalium... Vaginitis is quite common in Vietnamese women. This is an issue of great concern in public health care because sexually transmitted diseases often have mild or no symptoms, so they are easy to ignore. Besides, the use of broad-spectrum antibiotics can lead to side effects such as loss of appetite, fatigue and sexual problems, while repeated treatments can lead to the appearance of antibiotic resistance, poses a significant challenge to the treatment of BV and STDs worldwide. The disease is normally caused by the replacement of Lactobacillus (a group of beneficial bacteria of the vagina) leading to an overgrowth of anaerobic bacteria. Probiotics are microorganisms that are beneficial to human health when consumed in sufficient amounts, playing an important role in maintaining the balance of the body's microflora, especially in the intestines and vagina. Studies have found that probiotics may help reduce the incidence and severity of vaginal infections, including bacterial vaginosis and yeast infections. Currently, probiotics formulated as oral capsules or gynecological suppositories containing Bifidobacterium or Lactobacillus strains are being studied as a potential adjunctive therapy for the treatment of vaginal infections. However, these strains have low viability and are sensitive to temperature, humidity and pH, making preservation difficult. Their effectiveness therefore depends on the specific strains used and the dosage required to achieve high concentrations in the vaginal tract. Beneficial bacteria of the Bacillus genus have been studied for a long time for their safety. For example, Bacillus subtilis, B. clausii and B. coagulans are often aerobic or facultative anaerobic bacteria, capable of growing rapidly and forming spores that are resistant to harsh conditions such as lack of nutrition, lack of oxygen, high temperatures and even antibiotics. In addition, these bacteria are particularly well-suited for usage as direct and in-situ probiotic vaginal sprays since they can also secrete antibacterial compounds, lactic acid, H2O2, and activate the mucosal layer of intestinal immune system. The vaginal-spraying probiotic therapy helps support the treatment and prevention of sexually transmitted pathogens, providing a promising support/alternative solution to traditional antibiotic therapy.
The aim of this study is to assess if vaginal-spraying Bacillus probiotic spores can can reduce clinical symptoms and improve various sub-clinical markers of vaginitis patients.
Methods: Prospective design of randomized, double-blind, and controlled clinical trial. The experiment was conducted on women with vaginitis and the obtained data was compared either between 2 groups or among two-to-four time points of treatment period of the same group. The control group was applied the routine treatment at the hospital combined with spraying 0.9% NaCl physiological saline into the vagina 3 times/time x 2 times/day continuously for 28 days. The test group was applied routine treatment at the hospital combined with spraying LiveSpo X-SECRET into the vagina 3 times/time x 2 times/day continuously for 28 days.
Samples are taken at day 0 and one or more of the following time points: day 3, 7, 14, and/or 28, depending on each research unit's ability to control sampling at certain intervals during the treatment procedure. In details, samples were taken at day 0, 7, and 28 at Hanoi OGH; and at day 0, 3, 7, 14, 28 at Bac Ninh CDC. Sub-clinical indicators related to vaginitis was monitored at different time points, including:
98 studies on the registry are indexed under Vaginitis; 12 are open to participants now.
This study's enrollment of 120 is above the median of 108 across 71 interventional studies indexed under Vaginitis.
Browse Vaginitis studies →Anabio R&D is the lead sponsor of 12 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Control group receives the routine treatment and uses 0.9% NaCl physiological saline. The routine treatment regimen at Hanoi Obstetrics and Gynecology Hospital (Hanoi OGH) and Bac Ninh Center for Disease Control and Prevention (Bac Ninh CDC) depends on clinical symptoms, test results of bacterial staining and pathogen detected using multiplex real time PCR assay on day 0.
Drug: 0.9% NaCl physiological saline
X-SECRET group receives the routine treatment and uses NaCl 0.9% plus B. subtilis, B. clausii, and B. coagulans at 5 billion CFU/5 mL (LiveSpo®️ X-SECRET). The routine treatment regimen at Hanoi OGH and Bac Ninh CDC depends on clinical symptoms, test results of bacterial staining and pathogen detected using multiplex real time PCR assay on day 0.
Combination Product: LiveSpo X-secret
Vaginal-spraying 0.9% NaCl physiological saline is prepared by extracting 10 mL from 0.9% NaCl intravenous infusion 500 mL PP bottle (B.Braun, Germany, product declaration No. VD-32732-19), and then pouring it into the same opaque metallic spraying 20 mL-bottle.
Also known as: Registration number: VD-32723-19
In Vietnam, LiveSpo X-SECRET is manufactured as two product lines: (1) Class-A medical device product (Product declaration No.220003286/PCBA-HN) under manufacturing standards approved by Hanoi Department of Health, Ministry of Health, Vietnam and ISO 13485:2016 (Certificate No YT117-19) and (2) comestic (Product declaration No.14981/22/CBMP-HA) under manufacturing standards approved by Hanoi Department of Health, Ministry of Health, Vietnam (Certificate No 118/CNĐĐKSXMP. Both product lines have the same probiotic composition. The cosmetic type was used for the clinical trial conducted at Hanoi OGH. The Class-A medical device type was used for the clinical trial conducted at Bac Ninh CDC.
Also known as: Registration number: No.220003286/PCBA-HN, Registration number: 14981/22/CBMP-HA
Percentage of patients with free and/or reduced gynecological infection symptoms
Vulvar and vaginal ulcers (rating from 0 to 3 on a scale of: no ulcers - 0, labia minora ulcers, small, no pain-1, larger or painful ulcer - 2, very large, painful and rapidly spreading ulcer - 3) Inflammation (rating from 0 to 3 on a scale of: none - 0, mild redness or inflammation - 1, swelling or pain in vulva, vagina, or groin - 2, swollen lymph nodes and groin pain - 3) Itching (rating from 0 to 3 on a scale of: none - 0, mild itching or irritation - 1, itching, burning - 2, severe and persistent itching, burning - 3) Vaginal fluid color (uniform-clear white - 0, opalescent white - 1A, yellow/green - 1B; grey white - 1C) Vaginal odor (No/Yes) Painful/ painful urination (No/Yes) Lower abdominal pain (No/Yes) Abnormal vaginal bleeding (No/Yes)
Time frame: Day 0, 3, 7, 14, and 28
Changes in the vaginal pathogens load
Changes in the load or concentration of pathogens in vaginal samples, as indicated by real-time PCR threshold cycle (Ct) value at one or more of the following time points: day 3, 7, 14 and/or day 28 (after treatment) compared to day 0 (before treatment).
Time frame: Day 0, 3, 7, 14, and 28
Changes in immune indices in vaginal samples before and after treatment
Vaginal mucosal cytokines (pg/mL) including: interleukin-1β (IL-1β), interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-10 (IL-10), tumor necrosis factor-α TNF-α Vaginal mucosal (µg/mL) pro-inflammatory IgA.
Time frame: Day 0, 3, 7, 14, and 28
Changes in other patient's sub-clinical indicators in vaginal samples before and after treatment
* Clue cells (Negative/Positive) * Neisseria gonorrhoeae (Negative/Positive) * Fungi (Negative/Positive) * Trichomonas (Negative/Positive) * Vaginal epithelial cells (Negative/Positive)
Time frame: Day 0, 3, 7, 14, and 28
Changes in vaginal microbiota vaginal samples before and after treatment
Composition (diversity and abundance) of phylum, family, genus, and species of vaginal samples was analysed based on the data of 16S rRNA metagenome using next-generation sequencing (NGS). The analysis was carried out at day 7 or/ and day 28 (after treatment) compared with day 0 (before treatment).
Time frame: Day 0,7, and 28
Plan to share: Yes — Data or samples share that will be coded, with no PHI include. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Supporting information: Study protocol, Informed consent form, Clinical study report
Time frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
Access criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a study protocol, informed consent form (ICF), clinical study peport (CSR). For more information or to submit a request, please contact anabio.rd2021@gmail.com
Ran from Dec 2023 to primary completion in Dec 2024, 12 months.
Of 22 interventional studies with no phase under Vaginitis, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 35. This study's 12 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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