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

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ClinicalTrials.gov Identifier: NCT01599416
Recruitment Status : Completed
First Posted : May 16, 2012
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Human Papillomavirus Vaginal Infection Dietary Supplement: U-relax Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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

Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: same capsule appearance and bottle without any marks for identification to participants, care providers and investigators except serial numbers
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
Actual Study Start Date : June 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: U-relax Group
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

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




Primary Outcome Measures :
  1. Vaginal environment health check [ Time Frame: up to Day 360 ]
    PAP Test, general check and health condition questionnaire


Secondary Outcome Measures :
  1. HPV DNA Index Test Change [ Time Frame: Day 1, Day 360 ]
    HPV DNA Index Test, Health Condition Check



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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01599416


Locations
Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, Taiwan
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Study Director: Yu-Che Ou, MD CGMH
Principal Investigator: Hao Lin, MD CGMH

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01599416     History of Changes
Other Study ID Numbers: CGMH-O&G-201101TF01
99-0948A3 ( Other Identifier: CGMH )
First Posted: May 16, 2012    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: April 2012

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

Additional relevant MeSH terms:
Infection