Lactobacilli library for the next generation probiotics for women's health

JRCT ID: jRCT1070240104

Registered date:29/01/2025

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Pregnant women
• Date of first enrollment: 29/01/2025
• Target sample size: 366
• Study type: Observational

Outcome(s)

Primary Outcome

1.Isolation, identification and selection of Lactobacilli strains
2.Investigation of the relationship between Lactobacilli strains and pregnancy outcome / complications

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 50age old
• Gender: Female

Include criteria

1. Women aged between 20 and 50 years
2. Clinically confirmed pregnant women in the first trimester of pregnancy
3. Women who have given written consent to participate in the study
4. Healthy women without complications affecting pregnancy at the time of enrollment
5. Women who will manage their pregnancy and deliver at the study center where a specimen is collected.

Exclude criteria

1.Women who have antibiotics within the past four weeks prior to sampling.
2.Women who have taken probiotic products within the past four weeks prior to sampling.
3.Women with complications that may affect the course of pregnancy.
4.Women with underlying medical conditions that may negatively affect the vaginal microflora or pregnancy.
5.Women who perform excessive vaginal cleansing.
6.Women with acute illness or infection present at the time of specimen collection.
7.Women who have participated in a clinical trial that may affect the vaginal microflora within the past four weeks prior to sampling.
8.Women who have a history of excessive alcohol consumption or use of prohibited drugs.

Related Information

• Primary Sponsor: Mekaru Keiko
• Secondary Sponsor: Sante Laboratories, Inc.