Effects of LiveSpo X-secret in Supporting Treatment of Sexually Transmitted Diseases

NCT05783856 | Completed DMC

• 1 other identifier: IRB-1906
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Sexually Transmitted Infections (STIs) are common gynecological infections worldwide, especially in tropical and underdeveloped countries, primarily affecting the reproductive age group. Microbial pathogens causing STIs include bacteria, viruses, fungi, and protozoa. In Vietnam, STIs are a significant public health concern due to their high incidence and tendency to have mild or no symptoms, making them easy to overlook. While antibiotics or antifungal drugs are typically used to treat STIs caused by bacterial or fungal agents such as Chlamydia, Gonorrhea, and Candida, no specific treatment exists for most viral STIs. Thus, vaccination and symptomatic treatment are the primary methods of prevention. The use of broad-spectrum antibiotics can result in side effects such as loss of appetite, fatigue, and sexual problems, while repeated treatments can lead to the emergence of antibiotic resistance, posing a significant challenge for STI treatment worldwide. However, the efficacy of oral or suppository-based probiotics is limited by their slow onset and sensitivity to acidic and temperature conditions. Fortunately, Bacillus strains of probiotics have demonstrated exceptional stability in both acidic and temperature environments, making them particularly well-suited for use as vaginal spray probiotics against STIs. Here, investigators propose that vaginal-spraying probiotics containing Bacillus strains could be a safe and effective symptomatic treatment for STIs caused by viral, fungi, or bacterial pathogens, providing a promising alternative to traditional antibiotic therapy. The aim of the study about to evaluate the effectiveness of vaginal-spraying probiotics containing spores of three strains of Bacillus subtilis, Bacillus clausii, and Bacillus coagulans in preventing and supporting the treatment of vaginal infections. Study Population: sample size is 100. The study is being carried out at Bac Ninh Center for Disease Control. Description of Study Intervention: total of 100 eligible patients are divided randomly into 2 groups (n = 50/group): Patients in the Control group received routine treatment and 3 times/day 0.9% NaCl physiological saline while the patients in the experimental group were treated with LiveSpo X-secret 3 times/day in addition to the same standard of care treatment. The standard treatment regimen is 7 days and is maintained for 28 days. Study duration: 36 months

Conditions

Sexually Transmitted Diseases

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with free and/or reduced gynecological infection symptoms

  Percentage of patients with free gynecological infection including itching, odor, vaginal color, painful urination/ burning urine and lower abdominal pain * Vaginal itching/ odor level (rating from 0 to 3 on a scale of: None-0, Mild-1, Severe-2, Very severe-3) * Colored vaginal discharge (Clear white-0, Opaque-1,Yellow/green-2, Gray white-3) * Painful urination/ burning urine (Yes/No) * Lower abdominal pain (Yes/No)

  Day 0 to day 28

Secondary Outcomes (3)

• Change the vaginal pathogens load

  Day 0, 3, 7, 14, and day 28

• Change the vaginal pH values

  Day 0, 3, 7, 14, and day 28

• Change the vaginal flora

  Day 0, 7, and day 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 the Bac Ninh Center for Disease Control depends on the type of pathogen tested using multiplex real time PCR assay on day 0, as follows: Oral administrative medication based on the results of STIs pathogen detection test, antibiotic Clinidamycin (Withus Clinidamycin®) or/and the antifungal drug Itraconazole (Miduc®) are prescribed for 7 days to treat pathogenic bacteria or/and fungi infections, respectively. Vaginal suppository medication: Canvey®, which contains Metronidazole and Chloramphenicol, is only prescribed for further 7 days in the event that oral treatments of Clindamycin and Itraconazole have been unsuccessful.

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 the Bac Ninh Center for Disease Control depends on the type of pathogen tested using multiplex real time PCR assay on day 0, as follows: Oral administrative medication based on the results of STIs pathogen detection test, antibiotic Clinidamycin (Withus Clinidamycin®) or/and the antifungal drug Itraconazole (Miduc®) are prescribed for 7 days to treat pathogenic bacteria or/and fungi infections, respectively. Vaginal suppository medication: Canvey®, which contains Metronidazole and Chloramphenicol, is only prescribed for further 7 days in the event that oral treatments of Clindamycin and Itraconazole have been unsuccessful.

Combination Product: LiveSpo X-secret

Interventions

LiveSpo X-secret COMBINATION_PRODUCT

In Vietnam, LiveSpo X-secret is manufactured as a Class-A medical device product (Product declaration No.220003286/PCBA-HN) under manufacturing standards approved by Hanoi Health Department, Ministry of Health, Vietnam (Certificate No YT117-19) and ISO 13485:2016.

Also known as: Registration number: No.220003286/PCBA-HN

X-secret

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 15 mL-bottle that is used for LiveSpo X-secret.

Also known as: Registration number: VD-32723-19

Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Gynecological infections are related to the vaginal tract of women. We are currently testing on women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged from 18 to 60 years
• Amsel criteria for the diagnosis of vaginitis (presence of 3 of the following four criteria)
• Increased uniform thin vaginal discharge;
• pH of vaginal discharge greater than 4.5;
• Vaginal odor;
• STI positive detected by multiplex real-time PCR TaqMan probe for nine major vaginal pathogens circulating in Vietnam. These include Gardnerella vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis, Mycoplasma hominis, Mycoplasma genitalium, Human alphaherpesvirus type 1 and 2, Candida albicans, Trichomonas vaginalis;
• Patients agree to participate in the study after a thorough explanation of the research is provided to them, and they sign the research consent form.

You may not qualify if:

• Pregnant or nursing women, diabetics, taking antibiotics or antibiotics against vaginal infections in the previous 14 days.
• Unexplained vaginal bleeding or cancer.
• Having a history of drug allergies and hypersensitivity to any ingredient in probiotics or placebo.
• Discharged before day 7
• Meeting the criteria for psychiatric disorders other than depression and/or anxiety.

Sponsors & Collaborators

• Anabio R&D: lead
• Hanoi University of Science: collaborator

Study Sites (1)

Bac Ninh Center of Disease Control

Bắc Ninh, 16000, Vietnam

Location

Related Publications (26)

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Related Links

• Sexually transmitted infections (STIs)

MeSH Terms

Conditions

Sexually Transmitted Diseases; Vaginosis, Bacterial; Virus Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Ha TV Bui, PhD.

  VNU University of Sciences, Viet Nam National University

  PRINCIPAL INVESTIGATOR

• Anh TV Nguyen, PhD.

  Spobio Research Center, ANABIO R&D Ltd., Hanoi, Vietnam

  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 Blind, randomized, and controlled clinical trial

Study Record Dates

• First Submitted: March 11, 2023
• First Posted: March 24, 2023
• Study Start: May 3, 2020
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: April 4, 2023

Record last verified: 2023-04

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 clinicaltrial.probiotics@gmail.com

Locations

VN (1)