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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01599416
Other study ID # CGMH-O&G-201101TF01
Secondary ID 99-0948A3
Status Completed
Phase N/A
First received May 7, 2012
Last updated January 4, 2018
Start date June 2011
Est. completion date December 2013

Study information

Verified date April 2012
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date December 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Female
Age group 30 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Taiwan Kaohsiung Chang Gung Memorial Hospital Kaohsiung

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Vaginal environment health check PAP Test, general check and health condition questionnaire up to Day 360
Secondary HPV DNA Index Test Change HPV DNA Index Test, Health Condition Check Day 1, Day 360
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