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

Not Applicable

Completed

• Conditions: Intestinal Bacteria Flora Disturbance
• Interventions: Dietary Supplement: Babyguard® Breast Milk Probiotics; Dietary Supplement: Placebo

• Registration Number: NCT04672889
• Lead Sponsor: TCI Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2020-12-10
• Study First Submitted QC: 2020-12-15
• Study First Posted: 2020-12-17
• Study Start: 2021-11-01
• Primary Completion: 2024-09-30
• Study Completion: 2024-11-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Babyguard® Breast Milk Probiotics	Babyguard® Breast Milk Probiotics	consume 1 sachet per day for 1 months
Placebo	Placebo	consume 1 sachet per day for 1 months

Primary Outcome Measures

Name	Time	Method
Group. B Streptococcus (GBS) screening	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	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	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	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	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	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.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Zhongzheng District, Taiwan