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

NCT06069531 | Recruiting

• 1 other identifier: CS1-22188
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginitis Bacterial; Inflammation, Ear

Keywords

Bacterial Vaginitis; Probiotics; white pomegranate extract; Inflammation; Vaginal flora

Outcome Measures

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.

  16 weeks

Secondary Outcomes (1)

• Nugent score

  16 weeks

Study Arms (2)

Lactobacillus johnsonii,

PLACEBO COMPARATOR

heat-killed Lactobacillus johnsonii TCI250

Dietary Supplement: Lactobacillus johnsonii, Placebo Comparator: White pomegranate extract

White pomegranate extract

EXPERIMENTAL

White pomegranate extract, dosage of 500mg

Dietary Supplement: Lactobacillus johnsonii, Placebo Comparator: White pomegranate extract

Interventions

Lactobacillus johnsonii, Placebo Comparator: White pomegranate extract DIETARY_SUPPLEMENT

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

Also known as: Group A: Placebo, Group B: heat-killed Lactobacillus johnsonii TCI250, Group C: White pomegranate extract

Lactobacillus johnsonii,; White pomegranate extract

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Females aged 20-45
• Nugent score ≥ 4
• Menstrual cycle of 28-60 days

You may not qualify if:

• 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

Sponsors & Collaborators

• Chung Shan Medical University: lead
• TCI Co., Ltd.: collaborator

Study Sites (1)

Chung Shan Medical University Hospital

Taichung, 40201, Taiwan

RECRUITING

MeSH Terms

Conditions

Vaginosis, Bacterial; Otitis; Inflammation

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shih-Chien Huang

CONTACT

+886424730022; schuang@csmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 5, 2023
• Study Start: April 4, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)