High-risk human papillomavirus
Conditions
Interventions
Conventional Treatment and Care plus Oral Probiotics Group:Conventional Treatment and Care plus Oral Probiotics Group
Conventional Treatment and Care plus Oral Placebo Group:Conventional Treatment and Care plus Oral Placebo Group
Sponsors
Longgang Central Hospital, Shenzhen
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Confirmed positive for HR-HPV by HPV genotyping; 2.Meet one of the following two conditions: (1) Cytology indicating LSIL or ASC-US; (2) Colposcopic cervical biopsy pathology showing LSIL or below; 3.Aged between 18 and 65 years old; 4.Have not used probiotics or related products in the past month; 5.Have not received any HPV-related or antibiotic treatment in the past month; 6.Willing to cooperate with the research investigation and sign the informed consent form; 7.Not participating in any other clinical trials.
Exclusion criteria
Exclusion criteria: 1.Patients with cervical biopsy pathology showing grade 2–3 lesions or cancer after colposcopy; 2.Patients who have undergone conization or total hysterectomy within the past 6 months; 3.Patients with immune system diseases, corticosteroid treatment, severe comorbidities, gastrointestinal diseases, history of gastrointestinal surgery, or mental disorders; 4.Pregnant or breastfeeding women; 5.Patients allergic to probiotics or with poor compliance; 6.Patients who do not follow the study protocol or withdraw for any reason during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HR-HPV negative conversion rate;Cervical cytology abnormality clearance rate;Pathological reversal rate;Vaginal Microecology; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immune Inflammatory Cytokines;Sex Hormones;Gut Microbiota and Metabolites;Vaginal Microbiota and Metabolites; | — |
Countries
China
Contacts
Public ContactBin Wang
Longgang Central Hospital, Shenzhen
Outcome results
None listed