Influence of U-relax on Vaginal Health Promotion and HPV DNA Test Change From Positive to Negative
Primary Purpose
Human Papillomavirus, Vaginal Infection
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
U-relax
Sponsored by
About this trial
This is an interventional treatment trial for Human Papillomavirus focused on measuring Oral Probiotics, HPV DNA Index Test, Vaginal infection
Eligibility 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
Sites / Locations
- Kaohsiung Chang Gung Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
U-relax Group
Placebo Group
Arm Description
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
Day 1-5: take two capsuals of oral placebo everyday before sleep Day 6-360: take one capsual of oral placebo everyday before sleep
Outcomes
Primary Outcome Measures
Vaginal environment health check
PAP Test, general check and health condition questionnaire
Secondary Outcome Measures
HPV DNA Index Test Change
HPV DNA Index Test, Health Condition Check
Full Information
NCT ID
NCT01599416
First Posted
May 7, 2012
Last Updated
January 4, 2018
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01599416
Brief Title
Influence of U-relax on Vaginal Health Promotion and HPV DNA Test Change From Positive to Negative
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
June 2011 (Actual)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papillomavirus, Vaginal Infection
Keywords
Oral Probiotics, HPV DNA Index Test, Vaginal infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigator
Masking Description
same capsule appearance and bottle without any marks for identification to participants, care providers and investigators except serial numbers
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
U-relax Group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Day 1-5: take two capsuals of oral placebo everyday before sleep Day 6-360: take one capsual of oral placebo everyday before sleep
Intervention Type
Dietary Supplement
Intervention Name(s)
U-relax
Other Intervention Name(s)
GR-1 and RC-14
Intervention Description
Oral U-relax Day 1-5: 2 capsuals before sleep Day 6-360: 1 capsual before sleep
Primary Outcome Measure Information:
Title
Vaginal environment health check
Description
PAP Test, general check and health condition questionnaire
Time Frame
up to Day 360
Secondary Outcome Measure Information:
Title
HPV DNA Index Test Change
Description
HPV DNA Index Test, Health Condition Check
Time Frame
Day 1, Day 360
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Che Ou, MD
Organizational Affiliation
CGMH
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hao Lin, MD
Organizational Affiliation
CGMH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
31340789
Citation
Ou YC, Fu HC, Tseng CW, Wu CH, Tsai CC, Lin H. The influence of probiotics on genital high-risk human papilloma virus clearance and quality of cervical smear: a randomized placebo-controlled trial. BMC Womens Health. 2019 Jul 24;19(1):103. doi: 10.1186/s12905-019-0798-y.
Results Reference
derived
Learn more about this trial
Influence of U-relax on Vaginal Health Promotion and HPV DNA Test Change From Positive to Negative
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