Influence of U-relax on Vaginal Health Promotion and HPV... | NCT01599416

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

NCT01599416

Sponsor

Chang Gung Memorial Hospital

Status

Completed

Last Update Posted

Jan 5, 2018Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Human Papillomavirus
Vaginal Infection

Interventions

U-relax

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
99-0948A3	Other Identifier	CGMH

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011Actual

Primary Completion Date

Jun 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

May 7, 2012

First Submission Date that Met QC Criteria

May 15, 2012

First Posted Date

May 16, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 4, 2018

Last Update Posted Date

Jan 5, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
U-relax Group	Active Comparator	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
Placebo Group	Placebo Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
U-relax	Dietary Supplement	Oral U-relax Day 1-5: 2 capsuals before sleep Day 6-360: 1 capsual before sleep	Placebo Group U-relax Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Vaginal environment health check	PAP Test, general check and health condition questionnaire	up to Day 360

Secondary Outcomes

Measure	Description	Time Frame
HPV DNA Index Test Change	HPV DNA Index Test, Health Condition Check	Day 1, Day 360

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yu-Che Ou, MD	CGMH	Study Director
Hao Lin, MD	CGMH	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kaohsiung Chang Gung Memorial Hospital		Kaohsiung City			Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31340789	Derived	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.

ID	Term
D014623	Vaginal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications