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

NCT01599416 | Completed DMC

• 2 other identifiers: CGMH-O&G-201101TF0199-0948A3
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Papillomavirus; Vaginal Infection

Keywords

Oral Probiotics; HPV DNA Index Test; Vaginal infection

Outcome Measures

Primary Outcomes (1)

• Vaginal environment health check

  PAP Test, general check and health condition questionnaire

  up to Day 360

Secondary Outcomes (1)

• HPV DNA Index Test Change

  Day 1, Day 360

Study Arms (2)

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

U-relax DIETARY_SUPPLEMENT

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

Also known as: GR-1 and RC-14

Placebo Group; U-relax Group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• cervical intraepithelial neoplasia before conization
• cervical cancer patient
• with GI surgery
• GI dysfunction
• need for long-term antibiotics treatment

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 31340789 DERIVED

MeSH Terms

Conditions

Vaginitis

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Yu-Che Ou, MD

  CGMH

  STUDY DIRECTOR

• Hao Lin, MD

  CGMH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: same capsule appearance and bottle without any marks for identification to participants, care providers and investigators except serial numbers
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 7, 2012
• First Posted: May 16, 2012
• Study Start: June 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 5, 2018

Record last verified: 2012-04

Locations

TW (1)