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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01599416

Enrollment

Registered

2012-05-16

Start date

2011-06-30

Completion date

2013-12-31

Last updated

2018-01-05

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

Conditions

Human Papillomavirus, Vaginal Infection

Keywords

Oral Probiotics, HPV DNA Index Test, Vaginal infection

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.

Interventions

DIETARY_SUPPLEMENTU-relax

Oral U-relax Day 1-5: 2 capsuals before sleep Day 6-360: 1 capsual before sleep

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Masking description

same capsule appearance and bottle without any marks for identification to participants, care providers and investigators except serial numbers

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

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Vaginal environment health check	up to Day 360	PAP Test, general check and health condition questionnaire

Secondary

Measure	Time frame	Description
HPV DNA Index Test Change	Day 1, Day 360	HPV DNA Index Test, Health Condition Check

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026