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Completed

NCT Number: NCT01599416

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

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.

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Key information

Conditions

Human Papillomavirus Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Vaginal Diseases Vaginal Infection Vaginitis

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

U-relax

Dietary Supplement

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

Other names: GR-1 and RC-14

Primary outcomes

  1. Vaginal environment health check

    Time frame: up to Day 360

    PAP Test, general check and health condition questionnaire

Secondary outcomes

  1. HPV DNA Index Test Change

    Time frame: Day 1, Day 360

    HPV DNA Index Test, Health Condition Check

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 16, 2012
Registry last updated
Jan 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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