Analysis of Ameliorative Effects of Oral Probiotics on Bacterial Vaginosis

GenMont Biotech

Status: Completed

Conditions: Bacterial Vaginosis

Treatments: Dietary Supplement: probiotics

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03116789

NP105004

Details and patient eligibility

About

The purpose of this study is to analyze the ameliorative effects of oral probiotics on bacterial vaginosis.

Full description

To analyze the oral Lactobacillus rhamnosus with Lactobacillus acidophilus or Lactobacillus rhamnosus with Lactobacillus plantarum could be ameliorative effects for bacterial vaginosis.

Enrollment: 43 patients

Sex: Female

Ages: 20 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed Consent Form.
• Subjects with bacterial vaginosis and Nugent score as 4-10
• Subjects in age of 20-55 years old
• Regularly menstruating premenopausal women (normal menstrual function (Eumenorrhoea) shall mean regular menstrual bleeding pattern every 28 plus/minus 10 days)
• Forbidden sexual behavior was required 72 hours before all visits

Exclusion criteria

• Subjects are pregnant, lactating or planning to become pregnant.
• Allergy to test products (raw material components included: Anhydrous glucose, Magnesium stearate, Fructooligosaccharides, Microcrystalline cellulose, Lactobacillus, etc.)
• Bleeding from genital tract of unknown aetiology.
• Congenital and acquired immunodeficiencies.
• Diabetes
• Mental illness
• Malignant tumor
• Application of NuvaRing hormonal contraceptive vaginal ring
• Application of mechanical contraceptives, such as: diaphragms, intrauterine contraceptive insert, except condom
• Application of hormonal preparations, such as: Vagifem, Ovestin and vaginal estrogens in reproductive period.
• Mycotic vaginitis
• Antibiotic(unless indicated by PI) and steroids therapy during this trial.
• Use of oral or vaginal probiotic products (sachet, capsule, or tablet) four weeks before V1.
• Participation in another clinical study.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

43 participants in 2 patient groups

VGA-1(Probiotics)

Active Comparator group

Description:

Lactobacillus rhamnosus and Lactobacillus acidophilus.

Treatment:

Dietary Supplement: probiotics

VGA-2(Probiotics)

Active Comparator group

Description:

Lactobacillus rhamnosus and Lactobacillus plantarum.

Treatment:

Dietary Supplement: probiotics