Influence of U-relax on Vaginal Health Promotion and HPV DNA Test Change From Positive to Negative

Not Applicable

Completed

• Conditions: Human Papillomavirus; Vaginal Infection
• Interventions: Dietary Supplement: U-relax

• Registration Number: NCT01599416
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Study Start: 2011-06
• Status Verified: 2012-04
• Study First Submitted: 2012-05-07
• Study First Submitted QC: 2012-05-15
• Study First Posted: 2012-05-16
• Primary Completion: 2013-06
• Study Completion: 2013-12
• Last Update Submitted: 2018-01-04
• Last Update Posted: 2018-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	U-relax	Day 1-5: take two capsuals of oral placebo everyday before sleep Day 6-360: take one capsual of oral placebo everyday before sleep
U-relax Group	U-relax	Day 1-5: take two capsuals of oral U-relax everyday before sleep Day 6-360: take one capsual of oral U-relax everyday before sleep

Primary Outcome Measures

Name	Time	Method
Vaginal environment health check	up to Day 360	PAP Test, general check and health condition questionnaire

Secondary Outcome Measures

Name	Time	Method
HPV DNA Index Test Change	Day 1, Day 360	HPV DNA Index Test, Health Condition Check

Trial Locations

Locations (1)

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan