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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Intestinal Bacteria Flora Disturbance

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: Babyguard® Breast Milk Probiotics


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>consume 1 sachet per day for 1 months | Dietary Supplement: Placebo<br>* consume 1 sachet per day for 1 months<br>|
| Experimental: Babyguard® Breast Milk Probiotics<br>consume 1 sachet per day for 1 months | Dietary Supplement: Babyguard® Breast Milk Probiotics<br>* consume 1 sachet per day for 1 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microflora of mother's feces | 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. | 4-6 weeks after the baby is born | 
| Group. B Streptococcus (GBS) screening | Use sterile cotton sticks for vaginal samples, and then perform Group. B Streptococcus (GBS) screening | 35-37 weeks of pregnancy | 
| The microflora of maternal blood | 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 | 4-6 weeks after the baby is born | 
| Metabolic analysis of maternal urine | 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. | 4-6 weeks after the baby is born | 
| Bacteria analysis of breast milk | 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. | 4-6 weeks after the baby is born | 
| Bacteria analysis of infant feces | 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. | 4-6 weeks after the baby is born |