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

Intestinal Bacteria Flora Disturbance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04672889
• Other study ID #: 201703031RINC
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2023
• Source: TCI Co., Ltd.
• Contact: Ming Shiang Wu, Professor
• Phone: 23123456
• Email: mingshaing[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysbiosis
• Intestinal Bacteria Flora Disturbance

Intervention

Dietary Supplement:
• Placebo
consume 1 sachet per day for 1 months
• Babyguard® Breast Milk Probiotics
consume 1 sachet per day for 1 months

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei	Zhongzheng District

Sponsors (1)

Lead Sponsor	Collaborator
TCI Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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