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The Influence of Oral Probiotic on the Vaginal Flora and Microenvironment Alteration in the Vaginosis Infection Women

Primary Purpose

Probiotic, Human Papillomavirus Infection, Pap Smear, Microbiome

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
probiotic:Lactobacillus crispatus
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Probiotic, Human Papillomavirus Infection, Pap Smear, Microbiome

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: diagnosed as vaginal viginitis willing to sign permit willing to regular follow up Exclusion Criteria: Pregnant Virgin Severe cervix pathology CINII or CIN III Confirmed cervical cancer under long term antibiotics due to other physical condition

Sites / Locations

  • Kaohsiung Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

probiotic intervention

placebo

Arm Description

probiotic group with daily treatment

placebo-controlled with daily treatment

Outcomes

Primary Outcome Measures

improvement alteration of vaginal microbiome
16s rRNA

Secondary Outcome Measures

Full Information

First Posted
August 14, 2023
Last Updated
August 14, 2023
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06001190
Brief Title
The Influence of Oral Probiotic on the Vaginal Flora and Microenvironment Alteration in the Vaginosis Infection Women
Official Title
The Influence of Oral Probiotic on the Vaginal Flora and Microenvironment Alteration in the Vaginosis Infection Women
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2023 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
A single-blind, randomized, and probiotic-treatment including adult women with vaginitis and/or HPV positive. After oral probiotics, all participants will be followd-up cervical swabs and vaginal microbiome alteration till the end of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Probiotic, Human Papillomavirus Infection, Pap Smear, Microbiome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
probiotic intervention
Arm Type
Active Comparator
Arm Description
probiotic group with daily treatment
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo-controlled with daily treatment
Intervention Type
Dietary Supplement
Intervention Name(s)
probiotic:Lactobacillus crispatus
Intervention Description
We seek to observe that probiotic supplement(arm A) can improve vagina microbiome distribution by comapred to placebo group(arm B) in our study.
Primary Outcome Measure Information:
Title
improvement alteration of vaginal microbiome
Description
16s rRNA
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: diagnosed as vaginal viginitis willing to sign permit willing to regular follow up Exclusion Criteria: Pregnant Virgin Severe cervix pathology CINII or CIN III Confirmed cervical cancer under long term antibiotics due to other physical condition
Facility Information:
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu-Che Ou, MD
Phone
+886-7-732-7123
Ext
8916
Email
tedycou@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

The Influence of Oral Probiotic on the Vaginal Flora and Microenvironment Alteration in the Vaginosis Infection Women

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