Analysis of Ameliorative Effects of Oral Probiotics on Bacterial Vaginosis

Bacterial Vaginosis Clinical Trial

Official title:

Analysis of Ameliorative Effects of Oral Probiotics on Bacterial Vaginosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03116789
• Other study ID #: NP105004
• Status: Completed
• Phase: N/A
• Start date: April 11, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2020
• Source: GenMont Biotech Incorporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Dietary Supplement:
• probiotics
Two capsules for daily

Locations

Country	Name	City	State
Taiwan	KUO general hospital	Tainan

Sponsors (2)

Lead Sponsor	Collaborator
GenMont Biotech Incorporation	Kuo General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nugent Score	The degree of decline for Nugent score	4 weeks
Secondary	Vaginal pH	Vaginal pH value changes	4 weeks
Secondary	Vaginal secretions microflora	Changes in vaginal secretions microflora	4 weeks