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

Chang Gung Medical Foundation

Status: Enrolling

Conditions: Probiotic, Human Papillomavirus Infection, Pap Smear, Microbiome

Treatments: Dietary Supplement: probiotic:Lactobacillus crispatus

Study type: Interventional

Funder types: Other

Identifiers

NCT06001190

CORPG6M0171

Details and patient eligibility

About

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.

Enrollment: 76 estimated patients

Sex: Female

Ages: 20 to 75 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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76 participants in 2 patient groups, including a placebo group

probiotic intervention

Active Comparator group

Description:

probiotic group with daily treatment

Treatment:

Dietary Supplement: probiotic:Lactobacillus crispatus

placebo

Placebo Comparator group

Description:

placebo-controlled with daily treatment

Treatment:

Dietary Supplement: probiotic:Lactobacillus crispatus