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

Effect of Oral Probiotic Heat-killed Lactobacillus Johnsonii TCI250 or White Pomegranate Extract on the Vaginal Flora

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.

Study Overview

• Status: Recruiting
• Conditions: Vaginitis Bacterial; Inflammation, Ear
• Intervention / Treatment: Dietary supplement: Lactobacillus johnsonii, Placebo Comparator: White pomegranate extract

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

   iii. 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.

2. 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.
3. 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.
4. 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 Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shih-Chien Huang; Phone Number: +886424730022; Email: schuang@csmu.edu.tw

Study Locations

• Taiwan
  • Taichung City, Taiwan, 40201
    • Recruiting
    • Chung Shan Medical University Hospital
    • Contact: Shih-Chien Huang, assistant professor; Phone Number: 12009 +886424730022; Email: schuang@csmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	16 weeks

Collaborators and Investigators

• Sponsor: Chung Shan Medical University
• Collaborators: TCI Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2023
• Primary Completion (Estimated): September 16, 2024
• Study Completion (Estimated): September 16, 2024

Study Registration Dates

• First Submitted: October 2, 2023
• First Submitted That Met QC Criteria: October 2, 2023
• First Posted (Actual): October 5, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Inflammation; Probiotics; Vaginal flora; Bacterial Vaginitis; white pomegranate extract
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Otorhinolaryngologic Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Ear Diseases; Vaginal Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Inflammation; Vaginitis; Otitis; Vaginosis, Bacterial
• Other Study ID Numbers: CS1-22188

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No