Bacterial Vaginosis Clinical Trial
Official title:
Analysis of Ameliorative Effects of Oral Probiotics on Bacterial Vaginosis
Verified date | February 2020 |
Source | GenMont Biotech Incorporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to analyze the ameliorative effects of oral probiotics on bacterial vaginosis.
Status | Completed |
Enrollment | 43 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Informed Consent Form. - Subjects with bacterial vaginosis and Nugent score as 4-10 - Subjects in age of 20-55 years old - Regularly menstruating premenopausal women (normal menstrual function (Eumenorrhoea) shall mean regular menstrual bleeding pattern every 28 plus/minus 10 days) - Forbidden sexual behavior was required 72 hours before all visits Exclusion Criteria: - Subjects are pregnant, lactating or planning to become pregnant. - Allergy to test products (raw material components included: Anhydrous glucose, Magnesium stearate, Fructooligosaccharides, Microcrystalline cellulose, Lactobacillus, etc.) - Bleeding from genital tract of unknown aetiology. - Congenital and acquired immunodeficiencies. - Diabetes - Mental illness - Malignant tumor - Application of NuvaRing hormonal contraceptive vaginal ring - Application of mechanical contraceptives, such as: diaphragms, intrauterine contraceptive insert, except condom - Application of hormonal preparations, such as: Vagifem, Ovestin and vaginal estrogens in reproductive period. - Mycotic vaginitis - Antibiotic(unless indicated by PI) and steroids therapy during this trial. - Use of oral or vaginal probiotic products (sachet, capsule, or tablet) four weeks before V1. - Participation in another clinical study. |
Country | Name | City | State |
---|---|---|---|
Taiwan | KUO general hospital | Tainan |
Lead Sponsor | Collaborator |
---|---|
GenMont Biotech Incorporation | Kuo General Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Nugent Score | The degree of decline for Nugent score | 4 weeks | |
Secondary | Vaginal pH | Vaginal pH value changes | 4 weeks | |
Secondary | Vaginal secretions microflora | Changes in vaginal secretions microflora | 4 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03930745 -
Suppression Of Bacterial Vaginosis (BV) [SUBVert]
|
Phase 2 | |
Completed |
NCT02863536 -
A Study of the New Medical Device Polybactum®
|
N/A | |
Completed |
NCT03187457 -
PreFem: "What Happens to the Vaginal Microbiota When a BV Infection is Treated With Metronidazole?"
|
N/A | |
Recruiting |
NCT02185456 -
Validation of a Novel Diagnostic, Prognostic Assay for Bacterial Vaginosis
|
Phase 0 | |
Completed |
NCT02150655 -
Study of the Microbiota, Metabolome, and Environmental Toxins in Relation to Reproductive Health in Rwandan Women
|
Phase 0 | |
Completed |
NCT01450462 -
Vitamin D and Sexual Health
|
N/A | |
Recruiting |
NCT01558388 -
Probiotic Versus Placebo as Adjuvant for Bacterial Vaginosis Treatment During Pregnancy
|
Phase 4 | |
Not yet recruiting |
NCT00889356 -
Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin and Ketoconazole for the Treatment of Mixed-Type Vaginosis, Bacterial Vaginosis and Candidiasis
|
Phase 3 | |
Completed |
NCT01471457 -
Trial of Trimosan Gel Effect on Pessary-associated Bacterial Vaginosis
|
Phase 2/Phase 3 | |
Completed |
NCT00545181 -
Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial
|
N/A | |
Completed |
NCT00556179 -
Lactoserum (Dermacyd Femina®) and Prevention of Recurrence of Bacterial Vaginosis
|
Phase 4 | |
Completed |
NCT02236156 -
Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)
|
Phase 3 | |
Not yet recruiting |
NCT05434104 -
The LISA (Lactoferrin InStead of Antibiotics/Antifungals) Feasibility Study
|
N/A | |
Completed |
NCT01335373 -
Observational Program Neo-Penotran® Forte
|
N/A | |
Completed |
NCT00752193 -
Safety and Efficacy of a Vaginally Administered Probiotic Lactobacilli Delivery System.
|
N/A | |
Active, not recruiting |
NCT00536848 -
The Effect of Probiotics on the Immune Status, Diarrhea and Bacterial Vaginosis Cure Rate Among HIV Patients
|
Phase 2/Phase 3 | |
Completed |
NCT00510614 -
Tinidazole for Recurrent Bacterial Vaginosis: A Pilot Study
|
Phase 0 | |
Suspended |
NCT00207480 -
Brief, Behavioral Intervention to Reduce Douching Among Adolescent and Young Women
|
Phase 1 | |
Recruiting |
NCT05278130 -
Serial Screening and Treatment of Bacterial Vaginosis Trial
|
N/A | |
Completed |
NCT02905890 -
The Effect of Norethisterone Enanthate on Recurrent Bacterial Vaginosis
|
Phase 4 |