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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Chang Gung Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01599416
First received: May 7, 2012
Last updated: May 15, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Human Papillomavirus
Vaginal Infection
Dietary Supplement: U-relax
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Vaginal environment health check [ Time Frame: up to Day 360 ] [ Designated as safety issue: Yes ]
    PAP Test, general check and health condition questionnaire


Secondary Outcome Measures:
  • HPV DNA Index Test Change [ Time Frame: Day 1, Day 360 ] [ Designated as safety issue: Yes ]
    HPV DNA Index Test, Health Condition Check


Estimated Enrollment: 80
Study Start Date: June 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Dietary Supplement: U-relax
Oral U-relax Day 1-5: 2 capsuals before sleep Day 6-360: 1 capsual before sleep
Other Name: GR-1 and RC-14

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

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01599416

Contacts
Contact: Yu-Che Ou, MD +886-7-732-7123 ext 8916 tedycou@gmail.com
Contact: Hao Lin, MD +886-7-732-7123 ext 8916 haolin@adm.cgmh.org.tw

Locations
Taiwan
Kaohsiung Chang Gung Memorial Hospital Recruiting
Kaohsiung, Taiwan
Contact: Yu-Che Ou, MD    +886-7-732-7123 ext 8916      
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Study Director: Yu-Che Ou, MD CGMH
Principal Investigator: Hao Lin, MD CGMH
  More Information

No publications provided

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01599416     History of Changes
Other Study ID Numbers: CGMH-O&G-201101TF01, 99-0948A3
Study First Received: May 7, 2012
Last Updated: May 15, 2012
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
Oral Probiotics
HPV DNA Index Test
Vaginal infection

Additional relevant MeSH terms:
Communicable Diseases
Infection

ClinicalTrials.gov processed this record on November 20, 2014