Effects of Lactobacillus johnsonii and White Pomegranate Extract on Vaginal Health
Effect of Oral Probiotic Heat-killed Lactobacillus Johnsonii TCI250 or White Pomegranate Extract on the Vaginal Flora
NA · Chung Shan Medical University · NCT06069531
This study is testing if a probiotic and white pomegranate extract can improve vaginal health for women dealing with bacterial vaginitis and inflammation.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 20 Years to 45 Years |
| Sex | Female |
| Sponsor | Chung Shan Medical University (other) |
| Locations | 1 site (Taichung) |
| Trial ID | NCT06069531 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of Lactobacillus johnsonii TCI250 probiotics and white pomegranate extract on female vaginal health, specifically targeting bacterial vaginitis and inflammation. A total of 150 female participants aged 20-45 will be randomly assigned to one of three groups: a placebo, the probiotic treatment, or the pomegranate extract, for a duration of 8 weeks. The study will monitor changes in vaginal flora and inflammation through various assessments at specified intervals. Participants will also provide information on their dietary habits and health conditions throughout the trial.
Who should consider this trial
Good fit: Ideal candidates for this study are females aged 20-45 with a Nugent score of 4 or higher.
Not a fit: Patients who are pregnant, lactating, or have other reproductive-related inflammatory diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatments for bacterial vaginitis and enhanced vaginal health in women.
How similar studies have performed: Previous studies have shown promise in using probiotics for vaginal health, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Females aged 20-45 2. Nugent score ≥ 4 3. Menstrual cycle of 28-60 days Exclusion Criteria: 1. Pregnant or lactating women 2. Antibiotic usage 3. Other reproductive-related inflammatory diseases (e.g., candidiasis, gonorrhea, chlamydia infection) 4. Allergy to probiotics or White Pomegranate-related components
Where this trial is running
Taichung
- Chung Shan Medical University Hospital — Taichung, Taiwan (RECRUITING)
Study contacts
- Study coordinator: Shih-Chien Huang
- Email: schuang@csmu.edu.tw
- Phone: +886424730022
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Vaginitis Bacterial, Inflammation, Ear, Bacterial Vaginitis, Probiotics, white pomegranate extract, Inflammation, Vaginal flora