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

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

Study Overview

• Status: Recruiting
• Conditions: Intestinal Bacteria Flora Disturbance
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Babyguard® Breast Milk Probiotics

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ming Shiang Wu, Professor; Phone Number: 65043 23123456; Email: mingshaing@ntu.edu.tw

Study Locations

• Taiwan
  • Zhongzheng District
    • Taipei, Zhongzheng District, Taiwan, 100225
      • Recruiting
      • National Taiwan University Hospital
      • Contact: Ming Shiang Wu, Professor; Phone Number: 65043 23123456; Email: mingshaing@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; consume 1 sachet per day for 1 months	Dietary supplement: Placebo; consume 1 sachet per day for 1 months
Experimental: Babyguard® Breast Milk Probiotics; consume 1 sachet per day for 1 months	Dietary supplement: Babyguard® Breast Milk Probiotics; consume 1 sachet per day for 1 months

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: TCI Co., Ltd.
• Investigators: Principal Investigator: Ming Shiang Wu, Doctor, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Anticipated): October 30, 2024
• Study Completion (Anticipated): December 30, 2024

Study Registration Dates

• First Submitted: December 10, 2020
• First Submitted That Met QC Criteria: December 15, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 14, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Dysbiosis
• Other Study ID Numbers: 201703031RINC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No