Probiotic Modulates Vaginal Microflora

Min-Tze LIONG

Status and phase: Completed; Phase 3; Phase 2

Conditions: Microbial Colonization

Treatments: Dietary Supplement: placebo; Dietary Supplement: Probiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT05302687

IREC 2021-318

Details and patient eligibility

About

The purpose of this study is to evaluate the effects of oral administration of probiotic at 9 log colony forming unit (CFU)/day on vaginal microbiota profiles compared to placebo via the use of vaginal self-swab microbiota profiling.

Full description

1. To evaluate differences in general women's health of women on probiotic and placebo via the use of questionnaire.
2. To evaluate differences in immunity of women on probiotic and placebo via blood immunity profiling.
3. To evaluate differences in gut microbiota profiles of women on probiotic and placebo via blood fecal microbiota profiling.

Enrollment: 112 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Generally, healthy women aged 18-80. - Currently free from urogenital infections such as urinary tract infection (UTI), bacterial vaginosis (BV), or yeast vaginitis.
• Willing to commit throughout the experiment.

Exclusion criteria

• Pregnant.
• On vaginal suppository treatments within 4-weeks prior to entering the study.
• On oral medication for vaginal illnesses or any vaginal therapy such as hormones and estrogen within 4-weeks prior to entering the study.
• On long term medication (> 6 months) for any illnesses.
• Have used vaginal estrogen cream, ring or tablet within 4-weeks prior to entering the study.
• Have used vaginal moisturizers, lubricants or homeopathic preparations within 4-weeks prior to entering the study.
• Have used spermicide agent within 4-weeks prior to entering the study.
• Pelvic or any gynecologic surgery 6-months prior to entering the study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

112 participants in 2 patient groups, including a placebo group

probiotic 9 log CFU/day

Experimental group

Description:

Intervention consists of daily administration of one sachet/day of probiotic for 12 weeks, where each sachet contains 9 log CFU of probiotic.

Treatment:

Dietary Supplement: Probiotic

placebo

Placebo Comparator group

Description:

placebo contains primarily carrier and without probiotic. The placebo are identical in taste and appearance and appear as light-yellow powder.

Treatment:

Dietary Supplement: placebo