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

NCT ID: NCT06001190

Last Updated: 2023-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-15

Study Completion Date

2024-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Probiotic, Human Papillomavirus Infection, Pap Smear, Microbiome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

probiotic intervention

probiotic group with daily treatment

Group Type ACTIVE_COMPARATOR

probiotic:Lactobacillus crispatus

Intervention Type DIETARY_SUPPLEMENT

We seek to observe that probiotic supplement(arm A) can improve vagina microbiome distribution by comapred to placebo group(arm B) in our study.

placebo

placebo-controlled with daily treatment

Group Type PLACEBO_COMPARATOR

probiotic:Lactobacillus crispatus

Intervention Type DIETARY_SUPPLEMENT

We seek to observe that probiotic supplement(arm A) can improve vagina microbiome distribution by comapred to placebo group(arm B) in our study.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

probiotic:Lactobacillus crispatus

We seek to observe that probiotic supplement(arm A) can improve vagina microbiome distribution by comapred to placebo group(arm B) in our study.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yu-Che Ou, MD

Role: primary

+886-7-732-7123 ext. 8916

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CORPG6M0171

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.