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

NCT ID: NCT01599416

Last Updated: 2018-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2013-12-31

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.

Conditions

Human Papillomavirus; Vaginal Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

U-relax

Intervention Type: DIETARY_SUPPLEMENT

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

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

Group Type: PLACEBO_COMPARATOR

U-relax

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

U-relax

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

GR-1 and RC-14

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yu-Che Ou, MD

Role: STUDY_DIRECTOR

CGMH

Hao Lin, MD

Role: PRINCIPAL_INVESTIGATOR

CGMH

Locations

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Countries

Taiwan

References

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.

Reference Type: DERIVED

PMID: 31340789 (View on PubMed)

Other Identifiers

99-0948A3

Identifier Type: OTHER

Identifier Source: secondary_id

CGMH-O&G-201101TF01

Identifier Type: -

Identifier Source: org_study_id