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Clinical Trials/NCT04672889
NCT04672889
Completed
Not Applicable

Use Babyguard® Breast Milk Probiotics to Verify the Authenticity of the Gut-Breast Axis Hypothesis

TCI Co., Ltd.1 site in 1 country30 target enrollmentNovember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intestinal Bacteria Flora Disturbance
Sponsor
TCI Co., Ltd.
Enrollment
30
Locations
1
Primary Endpoint
Group. B Streptococcus (GBS) screening
Status
Completed
Last Updated
last year

Overview

Brief Summary

In order to understand the life history of the breast milk flora, explore its composition, source of strains, and ability to colonize the baby's intestinal environment, to find out strains with the potential of probiotics in breast milk

Detailed Description

This is a double-blind and randomized study. After being discharged from the hospital, the subject was notified to consume the Babyguard breast milk probiotic daily for 1 month, and observe whether the mother's stool, breast milk and baby stool samples can find the same strain. The clinical diagnosis items of the bacterial strains of mother feces, breast milk and baby feces samples are evaluated by the doctor.

Registry
clinicaltrials.gov
Start Date
November 1, 2021
End Date
November 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • At least 20 years old, pregnant women with non-high-risk pregnancy risk assessed by obstetricians and gynecologists, healthy mothers and infants with no abnormal obstetric examination results

Exclusion Criteria

  • Pregnant women who have used oral or injectable antibiotics within three months before delivery, or women who need a cesarean section for any reason during pregnancy

Outcomes

Primary Outcomes

Group. B Streptococcus (GBS) screening

Time Frame: 35-37 weeks of pregnancy

Use sterile cotton sticks for vaginal samples, and then perform Group. B Streptococcus (GBS) screening

Bacteria analysis of infant feces

Time Frame: 4-6 weeks after the baby is born

Collect baby feces for bacterial phase analysis.Use Baby feces use Qiagen stool mini kit to extract DNA, and then use intestinal bacteria primers to detect the presence of intestinal bacteria in the feces.

Microflora of mother's feces

Time Frame: 4-6 weeks after the baby is born

Collect mother's feces for bacterial analysis.The mother's feces use Qiagen stool mini kit to extract DNA, and then use the intestinal bacteria primers to detect the presence of intestinal bacteria in the feces.

Bacteria analysis of breast milk

Time Frame: 4-6 weeks after the baby is born

Collect 10 ml of breast milk for bacterial phase analysis.Use Qiagen DNA isolation mini kit to extract DNA from breast milk, and then use intestinal bacteria primers to detect whether the breast milk contains intestinal bacteria.

The microflora of maternal blood

Time Frame: 4-6 weeks after the baby is born

Use venous blood to collect 20 ml of mother's blood for bacterial analysis.The mother's blood uses Qiagen DNA isolation mini kit to extract DNA, and then uses intestinal bacteria primers to detect the presence of intestinal bacteria in the blood

Metabolic analysis of maternal urine

Time Frame: 4-6 weeks after the baby is born

Collect 10 ml of mother's urine for intestinal dysbiosis analysis. Use Qiagen DNA isolation mini kit to extract DNA from the mother's urine, and then use the intestinal bacteria primer to detect the presence of intestinal bacteria in the urine.

Study Sites (1)

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