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Study on the Effects of Vaginal Microbiota Transplantation, Lactobacillus crispatus, and the Combination of Lactobacillus crispatus with Vaginal Supernatant on Vaginal Microbiota Reconstruction and Immune Regulation Without Antibiotic Intervention.

Study on the Effects of Vaginal Microbiota Transplantation, Lactobacillus crispatus, and the Combination of Lactobacillus crispatus with Vaginal Supernatant on Vaginal Microbiota Reconstruction and Immune Regulation Without Antibiotic Intervention.

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089960
Enrollment
Unknown
Registered
2024-09-20
Start date
2024-10-01
Completion date
Unknown
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

vaginal dysbiosis

Interventions

Lactobacillus crispatus transplantation group:Lactobacillus crispatus transplantation
Full-spectrum vaginal microbiota transplantation group:Full-spectrum vaginal microbiota transplantation group
Lactobacillus crispatus combined with vaginal supernatant transplantation group:Lactobacillus crispatus combined with vaginal supernatant transplantation
Blank control group:saline solution

Sponsors

The First Affiliated Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1: Here is the translation of your text into English: Donor Inclusion Criteria: 1. Inclusion Criteria:Age:18-40 years old, with regular menstruation. Reproductive health: No obvious reproductive tract symptoms, such as abnormal odor, unusual discharge, itching, or pain. Preliminary cervical mucus screening: No significant inflammation, and vaginal microecology indicates a balanced vaginal microbiota. Sexual activity:Must have a history of sexual activity. Agreement to comply with the protocol: Including avoiding sexual activity and refraining from using antibiotics or intravaginal products during the screening and donation period." 2: Inclusion Criteria for Patients: Women diagnosed with recurrent bacterial vaginosis (BV). Recurrent vaginitis is defined as experiencing three or more symptomatic episodes within the past year, requiring antibiotic maintenance therapy to remain asymptomatic, or recurrence occurring within =2 months after treatment, with no other underlying diseases.

Exclusion criteria

Exclusion criteria: 1: Donor Exclusion Criteria: Reproductive tract infections: Any diagnosis of sexually transmitted diseases (STDs) or vaginitis within the past year. Medication use: Use of oral or vaginal antibiotics within the past three months; use of probiotic products within the last 30 days; or any vaginal douching. Pregnancy and breastfeeding: Currently pregnant or breastfeeding. Other medical conditions: Any underlying conditions that could affect vaginal microbiota, such as diabetes or immunosuppressive diseases. Travel history: Residence in epidemic regions within the past six months. 2: Patient Exclusion Criteria: (1) Currently pregnant or planning pregnancy within the next year. (2) Infected with hepatitis B, hepatitis C, HIV, or syphilis. (3) Positive results for group A, B, C, or G streptococcus culture, urine culture, urinalysis, or serological analysis for herpes virus and cytomegalovirus. (4) Positive for HPV, Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium, or Trichomonas vaginalis.

Design outcomes

Primary

MeasureTime frame
Vaginal microbiota reconstruction Changes;Clinical symptom improvement;Immune regulation indicators;

Countries

China

Contacts

Public ContactTang Liangdan

The First Affiliated Hospital of Chongqing Medical University

330694469@qq.com+86 23 8901 1876

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026