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Effect of Lactobacillus Johnsonii or White Pomegranate Extract on the Vaginal Health

Sponsor
Chung Shan Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06069531
Collaborator
TCI Co., Ltd. (Industry)
150
Enrollment
1
Location
2
Arms
11.5
Anticipated Duration (Months)
13
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Lactobacillus johnsonii, Placebo Comparator: White pomegranate extract
 N/A

Detailed Description

This study is an interventional trial conducted in a randomized double-blind controlled study, we will recruit 150 participants. Participants will be randomly d divided into three groups (Group A: Placebo; Group B: heat-killed Lactobacillus johnsonii TCI250; Group C: White pomegranate extract, dosage of 500mg) for 8 weeks. Subsequently, participants will be followed up for an additional 8 weeks to observe changes in the vaginal microbiota and inflammation. At weeks 0, 4, 8, and 16, participants will record basic information such as personal dietary habits, lifestyle, and health conditions. Additionally, vaginal epithelial cells and whole blood (5 mL) will be collected at weeks 0, 8, and 16 for liver and kidney function monitoring (GPT, creatinine).

  1. Study Participants i. Inclusion Criteria (1) Females aged 20-45 (2) Nugent score ≥ 4 (3) Menstrual cycle of 28-60 days ii. 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
  1. Withdrawal Criteria Participants are free to decide whether to participate in this trial, and they can withdraw their consent at any time during the trial without providing any reason. If participants experience discomfort, they may withdraw from the trial at any time without facing any penalties or compromising their rights.

  1. Subject Recruitment Interested participants will be recruited openly through posters posted at Chung Shan Medical University Hospital. The researchers will explain the trial content for 15-20 minutes, and if interested, participants will sign the informed consent form.

  2. Research Methods i. Questionnaire assessment ii. Nugent score evaluation iii. Inflammatory markers detection: Including IL-4, IL-10, IL-6, IL-8, MCP-1, TNF-α, IL-1β. I iv. Microbiota gene sequencing: Utilizing 16S rRNA gene sequences to analyze the vaginal microbiota.

  3. Statistical Methods Data from this study will be analyzed using SigmaPlot statistical software (version 12.5; Systat Software, San Jose, CA) and SAS statistical software (version 9.4, Statistical Analysis System Institute Inc., Cary, NC, USA). One-way ANOVA will be used to compare differences among the three groups, repeated measurement ANOVA to compare pre- and post-intervention values within each group, and multiple linear regression to analyze the impact of supplement intake on vaginitis scores, inflammation, and microbiota diversity. The results will be presented as mean ± standard deviation (SD). Statistical significance will be indicated by p < 0.05.

Through this study, the administration of Lactobacillus johnsonii TCI250 probiotics and White Pomegranate extract is investigated for their effectiveness in improving the vaginal microbiota in women. This could potentially serve as a means of promoting vaginal health and well-being.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Effect of Oral Probiotic Heat-killed Lactobacillus Johnsonii TCI250 or White Pomegranate Extract on the Vaginal Flora
Anticipated Study Start Date :
Oct 2, 2023
Anticipated Primary Completion Date :
Sep 16, 2024
Anticipated Study Completion Date :
Sep 16, 2024

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Lactobacillus johnsonii,

heat-killed Lactobacillus johnsonii TCI250

Dietary Supplement: Lactobacillus johnsonii, Placebo Comparator: White pomegranate extract
Group A: Placebo; Group B: heat-killed Lactobacillus johnsonii TCI250; Group C: White pomegranate extract, dosage of 500mg for 8 weeks.
Other Names:
  • Group A: Placebo
  • Group B: heat-killed Lactobacillus johnsonii TCI250
  • Group C: White pomegranate extract

    		•
    Experimental: White pomegranate extract

    White pomegranate extract, dosage of 500mg

    Dietary Supplement: Lactobacillus johnsonii, Placebo Comparator: White pomegranate extract
    Group A: Placebo; Group B: heat-killed Lactobacillus johnsonii TCI250; Group C: White pomegranate extract, dosage of 500mg for 8 weeks.
    Other Names:
  • Group A: Placebo
  • Group B: heat-killed Lactobacillus johnsonii TCI250
  • Group C: White pomegranate extract

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Vaginal microbiota [16 weeks]

      Utilizing 16S rRNA gene sequences to analyze the vaginal microbiota.

    Secondary Outcome Measures

    1. Vaginal Inflammation [16 weeks]

      Evaluating the improvement of vaginal inflammation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chung Shan Medical University Hospital Taichung City Taiwan 40201

    Sponsors and Collaborators

    • Chung Shan Medical University
    • TCI Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shih Chien Huang, assistant professor, Chung Shan Medical University
    ClinicalTrials.gov Identifier:
    NCT06069531
    Other Study ID Numbers:
    • CS1-22188
    First Posted:
    Oct 5, 2023
    Last Update Posted:
    Oct 5, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Shih Chien Huang, assistant professor, Chung Shan Medical University
    Bacterial Vaginitis
    Probiotics
    white pomegranate extract
    Inflammation
    Vaginal flora
    Additional relevant MeSH terms:
    Vaginosis, Bacterial
    Otitis
    Vaginitis
    Inflammation

    Study Results

    No Results Posted as of Oct 5, 2023