Clinical trial NCT01599416: Influence of U-relax on Vaginal Health Promotion and HPV DNA Test Change From Positive to Negative
Official title: Randomized, Double-blind, Placebo-controlled Study ,Oral U-relax in the Influence of the Vaginal Environment Health Promotion, and the HPV DNA Test Index Change From Positive to Negative on the HPV Infection Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papillomavirus
Vaginal Infection
Keywords: Oral Probiotics
HPV DNA Index Test
Vaginal infection
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2012-05-16
Enrollment: 80
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: U-relax Group: U-relax capsules Day 1-5: take two capsuals of oral U-relax everyday before sleep Day 6-360: take one capsule of oral U-relax everyday before sleep

Control Group: Placebo capsules Day 1-5: take two capsuals of oral placebo everyday before sleep Day 6-360: take one capsual of oral placebo everyday before sleep
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to understand the effect of using oral U-relax on HPV infected women for vaginal environment health promotion, and the HPV DNA Test Index change from positive to negative. Long-term infection of HPV is associated with cervical cancer. U-relax contains Lactobacillus GR-1 and Lactobacillus RC-14 and has been approved of its benefits on treatment of BV, UTI, IBD and can improve vaginal environment health. Patients with positive result of HPV DNA test have no appropriate and aggressive treatment to reduce the risk of cervical cancer. This clinical trial tries to reveal the influence of oral U-relax and patients with HPV DNA test positive result.

Detailed description: This study is a prospective, double blind, randomized clinical trial. Vaginal health screening and HPV DNA Test are carried out from 80 patients with positive HPV DNA Test after conization for 6 months. All these patients will participant this study during the 360-day trial period. All health related conditions will be monitored at the same time.

Eligibility criteria: Inclusion Criteria:

* female
* age over 30
* PAP Test with NEGATIVE FOR INTRAEPITHELIAL LESION OR MALIGNANCY result
* HPV DNA Index Test with POSITIVE result after conization for 6 months
* not pregnant

Exclusion Criteria:

* cervical intraepithelial neoplasia before conization
* cervical cancer patient
* with GI surgery
* GI dysfunction
* need for long-term antibiotics treatment

Primary outcomes:
measure: Vaginal environment health check
timeFrame: up to Day 360
Secondary outcomes:
measure: HPV DNA Index Test Change
timeFrame: Day 1, Day 360
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
affiliation: CGMH
name: Yu-Che Ou, MD
role: STUDY_DIRECTOR
affiliation: CGMH
name: Hao Lin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ou YC, Fu HC, Tseng CW, Wu CH, Tsai CC, Lin H. The influence of probiotics on genital high-risk human papilloma virus clearance and quality of cervical smear: a randomized placebo-controlled trial. BMC Womens Health. 2019 Jul 24;19(1):103. doi: 10.1186/s12905-019-0798-y.