Oral Lactobacillus Crispatus LCr86 Reduces Nugent Score and Improves Vaginal Microecology in Women With Intermediate Vaginal Microbiota

Lactobacillus crispatus LCr86 was selected as a test preparation to evaluate its effect on the Nugent score, vaginal pH, vaginal microbiota composition, serum inflammatory cytokines, and functional prediction analyse.

Study Overview

• Status: Completed
• Conditions: Patients With Bacterial Vaginosis
• Intervention / Treatment: Dietary supplement: Probiotic; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215200
      • Zhao ruihang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Women of childbearing age over 19 years of age and under 50 years of age.
2. A person with a score of 4-6 on the Nugent core.
3. A person who agrees to participate in the human application test before the human application test begins and has prepared the written consent form.
4. A person who agrees to follow the contraception methods permitted by PI.

Exclusion Criteria:

1. Those who are currently being treated for severe cardiovascular system, immune system, respiratory system, gastrointestinal tract/liver and biliary system, kidney and urinary system, nervous system, musculoskeletal system, psychiatric, infectious disease, tumor and malignant.
2. The subjects who treated for vaginal or urinary tract infection as of within 3 months (e.g., candidiasis, trichomonas infection, gonorrhea, chlamydial infection, etc.).
3. The subjects with vaginal or urinary tract bleeding, or abnormality.
4. The subjects who has been given antibiotics, antimicrobial agents, steroids, immunosuppressants, estrogen-based drugs (pneumonia-related drugs are allowed) within 4 weeks of visit 1 (but those who used them within 2 weeks of visit 1 cannot participate in the test).
5. The subjects who has consumed health functional foods related to improving immune function and vaginal health.
6. The subjects who has administered probiotics and prebiotics within two weeks based on visit 1 or has continuously administered or ingested fermented milk and lactobacillus products.
7. Allergic constitution or hypersensitivity to known components of the study drug.
8. The subjects who has received salivary treatment for sedimentation, women's cleansers, vaginal sanitizers, left fumigation, and vaginal health within two week of screening visit.
9. The subjects with unregulated hypertension (above 160mmHg or 90mmHg of blood pressure).
10. The subjects who AST (GOT) or ALT (GPT) is at least three times the normal limit of the testing agency.
11. The subjects who are sensitive or allergic to the ingredients of this human-applied test food.
12. Subjects who are pregnant, breastfeeding, or planning to conceive within three months.
13. If the daily alcohol intake is more than 20g.
14. Excessive smokers (≥20 pieces/day).
15. The subjects who has participated in another interventional clinical trial within three month of the commencement of this trial or who has a plan to participate in another interventional clinical trial (including a human application test) after the commencement of this human application test.
16. The subjects who is deemed inappropriate by the human application test testers for this human application test.
17. Other vaginitis: Trichomonas vaginalis (TV) infection or fungal infection.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic group; 10B CFU/strip/day LCr86;	Dietary supplement: Probiotic; The experimental phase of this study will last 8 weeks and each subject will receive 4 follow-up visits (week 0, week 2, week 4, week 8).
Placebo Comparator: Placebo group; maltodextrin, one strip/day;	Dietary supplement: Placebo; The experimental phase of this study will last 8 weeks and each subject will receive 4 follow-up visits (week 0, week 2, week 4, week 8).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Nugent score	Vaginal swab specimens were Gram-stained and independently scored by two trained professionals according to the standard method. Nugent scores range from 0 to 10, with scores of 0-3 considered normal, 4-6 indicating an intermediate state, and 7-10 suggesting bacterial vaginosis.	8 weeks

Collaborators and Investigators

• Sponsor: Wecare Probiotics Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2025
• Primary Completion (Actual): January 10, 2026
• Study Completion (Actual): March 30, 2026

Study Registration Dates

• First Submitted: February 11, 2025
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): February 17, 2025

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections; Genital Diseases, Female; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Vaginosis, Bacterial; Vaginal Diseases; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Probiotics
• Other Study ID Numbers: WK2025005

Drug and device information, study documents

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