Effects of LiveSpo X-SECRET in SupportiveTreatment of Vaginitis

NCT06165354 | Completed DMC

• 2 other identifiers: TNLS.2023.XCS/PSHN/DC/23/38
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Vaginitis

Keywords

Bacterial vaginosis (BV); Sexually Transmitted Diseases (STDs); Vaginal-spraying probiotics; Bacillus spores; Bacteria; Fungi; Virus; Vietnamese women

Outcome Measures

Primary Outcomes (1)

• 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)

  Day 0, 3, 7, 14, and 28

Secondary Outcomes (4)

• Changes in the vaginal pathogens load

  Day 0, 3, 7, 14, and 28

• Changes in immune indices in vaginal samples before and after treatment

  Day 0, 3, 7, 14, and 28

• Changes in other patient's sub-clinical indicators in vaginal samples before and after treatment

  Day 0, 3, 7, 14, and 28

• Changes in vaginal microbiota vaginal samples before and after treatment

  Day 0,7, and 28

Study Arms (2)

Control

PLACEBO COMPARATOR

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

EXPERIMENTAL

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

Interventions

0.9% NaCl physiological saline DRUG

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

Control

LiveSpo X-secret COMBINATION_PRODUCT

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

X-secret

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Vagninitis infection in women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women from 18 to 60 years old
• Diagnosed with vaginitis with obvious symptoms and manifestations such as: vulvar/vaginal ulcers, inflammation, vaginal odor, vaginal itching, vaginal cololr, painful/ painful urination, lower abdominal pain; pain during sex; abnormal vaginal bleeding…
• Positive for one of the following pathogents that cause vaginitis, such as Gardnerella vaginalis, Mycoplasma hominis, Candida albicans, Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium, HSV-1, HSV-2, Trichomonas vaginalis, detected by real-time PCR assay.
• The patient agrees to participate in the study, explains and signs the consent form to participate in the study.

You may not qualify if:

• Women who are pregnant or breast-feeding, have diabetes, are using antibiotics/anti-inflammatory drugs in the vaginal area within the previous 14 days
• Vaginal bleeding of unknown cause or cancer
• Have a history of drug allergy and hypersensitivity to any ingredient in probiotics or placebo
• Leave the study before day 7
• Simultaneous participation in another clinical trial or use of probiotics for the gynecological tract within the past 14 days
• Meets criteria for mental, cognitive, depressive or anxiety disorders
• Do not agree to participate in the study

Sponsors & Collaborators

• Anabio R&D: lead
• Hanoi Obstetrics and Gynecology Hospital: collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (2)

Centers for Disease Control and Prevention

Bắc Ninh, Bac Ninh, 220000, Vietnam

Location

Hanoi Obstetrics and Gynecology Hospital

Ba Dinh, Hanoi, 100000, Vietnam

Location

Related Publications (14)

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  PMID: 41258468 DERIVED

MeSH Terms

Conditions

Vaginitis; Vaginosis, Bacterial; Sexually Transmitted Diseases; Virus Diseases

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chuong C Nguyen, MSc. MD

  Hanoi Obstetrics and Gynecology Hospital

  PRINCIPAL INVESTIGATOR

• Anh TV Nguyen, Assoc. Prof.

  Spobio Research Center, Anabio R&D

  PRINCIPAL INVESTIGATOR

• Thuy TB Nguyen, MSc. MD

  Hanoi Obstetrics and Gynecology Hospital

  PRINCIPAL INVESTIGATOR

• Ngoc TB Nguyen, MD

  Hanoi Obstetrics and Gynecology Hospital

  PRINCIPAL INVESTIGATOR

• Hong T Ngo, MSc

  Bac Ninh Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Huyen T Bui

  Spobio Research Center, Anabio R&D

  PRINCIPAL INVESTIGATOR

• Hao TN Vo

  Spobio Research Center, Anabio R&D

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: LiveSpo X-secret and placebo 0.9% NaCl physiological saline are indistinguishable regarding taste and smell. The color and turbidity of LiveSpo X-secret suspension is unrecognizable to investigators except the PI and analyzer due to opaque plastic container.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment Parallel Assignment Blind, randomized, and controlled clinical trial

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 11, 2023
• Study Start: December 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• 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

Locations

VN (2)