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Efficacy and safety of probiotics in bacterial vaginosis

Efficacy and safety of probiotics in bacterial vaginosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091295
Enrollment
Unknown
Registered
2024-10-24
Start date
2024-11-01
Completion date
Unknown
Last updated
2024-10-28

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

Conditions

Bacterial vaginosis

Interventions

Conventional antibiotic therapy:antibiotic therapy
Conventional antibiotics + oral probiotics:Antibiotic therapy + oral probiotics
Conventional antibiotics + probiotics for vaginal treatment:Antibiotics + vaginal probiotics
Conventional antibiotics + Probiotics vaginal treatment + oral probiotics:antibiotics + vaginal probiotics + oral probiotics
BV case group:None
Healthy control group:None

Sponsors

Ganzhou People 's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 45 Years

Inclusion criteria

Inclusion criteria: (1) The inclusion criteria of the normal control group (group C) were as follows: a. healthy women of childbearing age (20-45 years old) with regular menstrual cycles; b. No sexual life, vaginal irrigation and drug use history within 7 days before the examination; c. Vaginal secretions, cervical cancer screening and gynecological color ultrasonography showed no obvious abnormalities; d. No other chronic underlying diseases. (2) Inclusion criteria for bacterial vaginosis (Group B) : it met the diagnostic criteria for BV When diagnosing BV, care should be taken to rule out other common vaginal inflammation mixed infections. At present, the diagnosis of BV is mainly based on Amsel clinical diagnostic criteria and Gram staining Nugent score diagnostic criteria.

Exclusion criteria

Exclusion criteria: 1) Gonorrhea patients, genital herpes, and condyloma acuminatum; 2) Suffering from diseases of the reproductive system and other systems; 3) pregnancy; 4) lactating women; 5) Patients who underwent vaginal douching, spermicide use, and tampons within 7 days prior to treatment. 6) Abnormal HPV and TCT detection; 8) Use systemic drugs; ? Use probiotics (oral or vaginal); 9) Use traditional Chinese medicine or homeopathic medicine; 10) Acute diseases; 11) Tumor history; 12) Positive serological test for HIV, hepatitis C, hepatitis B, or syphilis. 13) History of gastrointestinal disease, autoimmune disease and immunomodulatory therapy, chronic pain and neuropsychiatric disorders, obesity (BMI>30). 14) No history of allergy to probiotics.

Design outcomes

Primary

MeasureTime frame
Clinical efficacy and recurrence rate of BV patients before and after treatment;

Secondary

MeasureTime frame
Vaginal flora in BV patients and healthy controls;Intestinal flora in BV patients and healthy controls;Changes of vaginal microflora in 4 groups of BV patients before and after treatment;Changes of intestinal flora in 4 groups of BV patients before and after treatment;

Countries

China

Contacts

Public ContactLiu Yan

Ganzhou People 's Hospital

l-clock@163.com+86 159 7083 0972

Outcome results

None listed

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