Phase 4
N=126
Probiotics as Adjuvant Treatment for Bacterial Vaginosis
Bacterial Vaginosis
Bottom Line
View on ClinicalTrials.gov: NCT03894813 ↗Enrolled (actual)
126
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Number of Participants With Related Clinical Signs or Symptoms at Baseline — 63; 63 Participants — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- "Probiotics" and "Metronidazole" (Drug); Metronidazole Vaginal (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Peking University Shenzhen Hospital
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Related Clinical Signs or Symptoms at Baseline |
63; 63 | <0.01 sig |
| PRIMARY Number of Participants With Clinically Effective in Each Study Arm in the 30-day Follow-up |
30; 28 | <0.01 sig |
| PRIMARY Number of Participants With Clinically Effective in Each Study Arm at the 90-day Follow-up |
19; 23 | <0.01 sig |
| PRIMARY Number of Participants With Bacteriological Cure in Each Study Arm at the 30-day Follow-up |
30; 28 | <0.01 sig |
| PRIMARY Number of Participants With Bacteriological Cure in Each Study Arm at the 90-day Follow-up |
19; 23 | <0.01 sig |
Summary
The investigators are trying to determine if oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (30 days)with metronidazole vaginal suppositories(7 days) is better than using metronidazole vaginal suppositories only in preventing the recurrence of bacterial vaginosis (BV).
Eligibility Criteria
Inclusion Criteria
- Aged 18 to 65 years old, with history of sexual activity, premenopausal women；
- Nugent Score ≥ 7 for diagnosing BV；
- Sign informed consent.
Exclusion Criteria
- mixed vaginitis, such as vulvovaginal candidiasis (VVC), Trichomonas vaginalis (TV) infection, Chlamydia trachomatis (CT) infection or gonococcal vaginitis;
- History of systemic organic diseases or psychiatric diseases;
- Planning for or during pregnancy, lactation, menstruation;
- within 5 days of onset of the disease, any antibiotics has been used;
- Long-term use of contraceptives or immunosuppressant;
- Anaphylactic constitution or allergic to known ingredients of research drugs.
Data sourced from ClinicalTrials.gov (NCT03894813). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.