Effect of Lactobacillus Johnsonii or White Pomegranate Extract on the Vaginal Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-45
SponsorChung Shan Medical University
About this trial
The goal of this clinical trial is to explore the effect of Lactobacillus johnsonii and white pomegranate extract on female bacterial status, it aims to answer are:
* Evaluate Lactobacillus johnsonii TCI250 probiotics or white pomegranate extract in regulating female vaginal bacteria and improving vaginal health. * Evaluate Lactobacillus johnsonii TCI250 probiotics or white pomegranate extract in regulating inflammation.
Participants will be randomly assigned to placebo (n = 50), probiotic heat-killed Lactobacillus johnsonii TCI250 group (n = 50) and white pomegranate extract group (n = 50) for 8 weeks. Researchers will compare the vaginal flora and inflammation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Females aged 20-45
Nugent score ≥ 4
Menstrual cycle of 28-60 days
Disqualifiers
Pregnant or lactating women
Antibiotic usage
Other reproductive-related inflammatory diseases (e.g., candidiasis, gonorrhea, chlamydia infection)
Allergy to probiotics or White Pomegranate-related components
Trial design
Design model
Parallel
Treatments tested in this trial
Lactobacillus johnsonii, Placebo Comparator: White pomegranate extract
Dietary supplementGroup A: Placebo; Group B: heat-killed Lactobacillus johnsonii TCI250; Group C: White pomegranate extract, dosage of 500mg for 8 weeks.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Lactobacillus johnsonii,Placebo comparator 1 intervention
Group B: White pomegranate extractExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Vaginal microbiota
Utilizing 16S rRNA gene sequences to analyze the vaginal microbiota, Expecting to increase the proportion of lactobacilli and decrease the proportion of Gardnerella in vaginal.
Time frame
16 weeksSecondary outcomes
1
Nugent score
The Nugent Score (0-10) is a Gram-stain scoring system for vaginal swabs for diagnosing bacterial vaginosis (BV). A score of 0 to 3 are considered negative for BV, 4-6 are considered BV-intermediate, and 7-10 are considered to indicate BV. This study anticipates a significant reduction in scores after supplementation, which signifies an improvement in BV.
Time frame
16 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Chung Shan Medical University
Lead sponsor
TCI Co., Ltd.
Collaborator
Source ClinicalTrials.gov