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Trial Title:
The Influence of Oral Probiotic on the Vaginal Flora and Microenvironment Alteration in the Vaginosis Infection Women
NCT ID:
NCT06001190
Condition:
Probiotic, Human Papillomavirus Infection, Pap Smear, Microbiome
Conditions: Official terms:
Infections
Communicable Diseases
Papillomavirus Infections
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Double (Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
probiotic:Lactobacillus crispatus
Description:
We seek to observe that probiotic supplement(arm A) can improve vagina microbiome
distribution by comapred to placebo group(arm B) in our study.
Arm group label:
placebo
Arm group label:
probiotic intervention
Summary:
A single-blind, randomized, and probiotic-treatment including adult women with vaginitis
and/or HPV positive. After oral probiotics, all participants will be followd-up cervical
swabs and vaginal microbiome alteration till the end of the study.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- diagnosed as vaginal viginitis
- willing to sign permit
- willing to regular follow up
Exclusion Criteria:
- Pregnant
- Virgin
- Severe cervix pathology CINII or CIN III
- Confirmed cervical cancer
- under long term antibiotics due to other physical condition
Gender:
Female
Minimum age:
20 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Kaohsiung Chang Gung Memorial Hospital
Address:
City:
Kaohsiung
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Yu-Che Ou, MD
Phone:
+886-7-732-7123
Phone ext:
8916
Email:
tedycou@gmail.com
Start date:
July 15, 2023
Completion date:
March 30, 2024
Lead sponsor:
Agency:
Chang Gung Memorial Hospital
Agency class:
Other
Source:
Chang Gung Memorial Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06001190
