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

• Sponsor: Chang Gung Memorial Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06001190
• Collaborator: (none)
• Enrollment: 76
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 8.5
• Patients Per Site Per Month: 8.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Probiotic, Human Papillomavirus Infection, Pap Smear, Microbiome	Dietary Supplement: probiotic:Lactobacillus crispatus	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 76 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: The Influence of Oral Probiotic on the Vaginal Flora and Microenvironment Alteration in the Vaginosis Infection Women
• Actual Study Start Date: Jul 15, 2023
• Anticipated Primary Completion Date: Feb 28, 2024
• Anticipated Study Completion Date: Mar 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: probiotic intervention probiotic group with daily treatment	Dietary Supplement: 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.
Placebo Comparator: placebo placebo-controlled with daily treatment	Dietary Supplement: 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.

Outcome Measures

Primary Outcome Measures

1. improvement alteration of vaginal microbiome [3 months]

   16s rRNA

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung		Taiwan

Sponsors and Collaborators

• Chang Gung Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chang Gung Memorial Hospital
• ClinicalTrials.gov Identifier: NCT06001190
• Other Study ID Numbers: CORPG6M0171
• First Posted: Aug 21, 2023
• Last Update Posted: Aug 21, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Communicable Diseases; Papillomavirus Infections

Study Results

No Results Posted as of Aug 21, 2023