Effects of LiveSpo X-secret in Supporting Treatment of Sexually Transmitted Diseases
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ClinicalTrials.gov Identifier: NCT05783856 |
Recruitment Status :
Completed
First Posted : March 24, 2023
Last Update Posted : April 4, 2023
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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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sexually Transmitted Diseases | Combination Product: LiveSpo X-secret Drug: 0.9% NaCl physiological saline | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Parallel Assignment Blind, randomized, and controlled clinical trial |
Masking: | Triple (Participant, Care Provider, Investigator) |
Masking Description: | 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 |
Primary Purpose: | Treatment |
Official Title: | Application of Vaginal-spraying LiveSpo X-secret in Supporting Treatment of Sexually Transmitted Diseases in Vietnamese Women |
Actual Study Start Date : | May 3, 2020 |
Actual Primary Completion Date : | March 31, 2023 |
Actual Study Completion Date : | March 31, 2023 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: Control
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
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.
Other Name: Registration number: VD-32723-19 |
Experimental: X-secret
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
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.
Other Name: Registration number: No.220003286/PCBA-HN |
- Percentage of patients with free and/or reduced gynecological infection symptoms [ Time Frame: Day 0 to day 28 ]
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)
- Change the vaginal pathogens load [ Time Frame: Day 0, 3, 7, 14, and day 28 ]Change the concentration of pathogens in vaginal samples, as indicated by real-time PCR threshold cycle (Ct) value at day 3, day 7, day 14 and day 28 (after treatment) compared with day 0 (before treatment)
- Change the vaginal pH values [ Time Frame: Day 0, 3, 7, 14, and day 28 ]Change the pH values of vaginal samples at day 3, day 7, day 14 and day 28 (after treatment) compared with day 0 (before treatment)
- Change the vaginal flora [ Time Frame: Day 0, 7, and day 28 ]Change the microbiome in vaginal flora, as indicated by the diversity of vaginal microbial species based on the data analysis of next-generation sequencing (NGS) at day 7 and day 28 (after treatment) compared with day 0 (before treatment)
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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Gynecological infections are related to the vaginal tract of women. We are currently testing on women. |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Women aged from 18 to 60 years
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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.
Exclusion Criteria:
- 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.
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): NCT05783856
Vietnam | |
Bac Ninh Center of Disease Control | |
Bac Ninh, Vietnam, 16000 |
Principal Investigator: | 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 |
Publications:
Responsible Party: | Anabio R&D |
ClinicalTrials.gov Identifier: | NCT05783856 |
Other Study ID Numbers: |
IRB-1906 |
First Posted: | March 24, 2023 Key Record Dates |
Last Update Posted: | April 4, 2023 |
Last Verified: | April 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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 Materials: |
Study Protocol Informed Consent Form (ICF) Clinical Study Report (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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Sexually Transmitted Diseases (STDs) Sexually Transmitted Infections (STIs) Bacterial vaginosis (BV) Vaginal-spraying probiotics Bacillus spores |
Pathogen load Fungi Virus Vietnamese women |
Sexually Transmitted Diseases Communicable Diseases Infections Genital Diseases |
Urogenital Diseases Disease Attributes Pathologic Processes |