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

NCT06830122 | Completed

• 1 other identifier: WK2025005
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Patients With Bacterial Vaginosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Probiotic group

EXPERIMENTAL

10B CFU/strip/day LCr86;

Dietary Supplement: Probiotic

Placebo group

PLACEBO COMPARATOR

maltodextrin, one strip/day;

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

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).

Probiotic group

Placebo DIETARY_SUPPLEMENT

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 group

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.
• The subjects who treated for vaginal or urinary tract infection as of within 3 months (e.g., candidiasis, trichomonas infection, gonorrhea, chlamydial infection, etc.).
• The subjects with vaginal or urinary tract bleeding, or abnormality.
• 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).
• The subjects who has consumed health functional foods related to improving immune function and vaginal health.
• 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.
• Allergic constitution or hypersensitivity to known components of the study drug.
• 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.
• The subjects with unregulated hypertension (above 160mmHg or 90mmHg of blood pressure).
• The subjects who AST (GOT) or ALT (GPT) is at least three times the normal limit of the testing agency.
• The subjects who are sensitive or allergic to the ingredients of this human-applied test food.
• Subjects who are pregnant, breastfeeding, or planning to conceive within three months.
• If the daily alcohol intake is more than 20g.
• Excessive smokers (≥20 pieces/day).
• 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.

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

Zhao ruihang

Suzhou, Jiangsu, 215200, China

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 17, 2025
• Study Start: July 15, 2025
• Primary Completion: January 10, 2026
• Study Completion: March 30, 2026
• Last Updated: May 26, 2026

Record last verified: 2026-05

Locations

CN (1)