Back to resultsUse Babyguard® Breast Milk Probiotics to Verify the Authenticity of the Gut-Breast Axis Hypothesis
Primary Purpose
Intestinal Bacteria Flora Disturbance
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Placebo
Babyguard® Breast Milk Probiotics
Sponsored by
About this trial
This is an interventional treatment trial for Intestinal Bacteria Flora Disturbance
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
Sites / Locations
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Babyguard® Breast Milk Probiotics
Arm Description
consume 1 sachet per day for 1 months
consume 1 sachet per day for 1 months
Outcomes
Primary Outcome Measures
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.
Group. B Streptococcus (GBS) screening
Use sterile cotton sticks for vaginal samples, and then perform Group. B Streptococcus (GBS) screening
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
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04672889
Brief Title
Use Babyguard® Breast Milk Probiotics to Verify the Authenticity of the Gut-Breast Axis Hypothesis
Official Title
Use Babyguard® Breast Milk Probiotics to Verify the Authenticity of the Gut-Breast Axis Hypothesis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
October 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TCI Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Bacteria Flora Disturbance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
consume 1 sachet per day for 1 months
Arm Title
Babyguard® Breast Milk Probiotics
Arm Type
Experimental
Arm Description
consume 1 sachet per day for 1 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
consume 1 sachet per day for 1 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Babyguard® Breast Milk Probiotics
Intervention Description
consume 1 sachet per day for 1 months
Primary Outcome Measure Information:
Title
Microflora of mother's feces
Description
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.
Time Frame
4-6 weeks after the baby is born
Title
Group. B Streptococcus (GBS) screening
Description
Use sterile cotton sticks for vaginal samples, and then perform Group. B Streptococcus (GBS) screening
Time Frame
35-37 weeks of pregnancy
Title
The microflora of maternal blood
Description
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
Time Frame
4-6 weeks after the baby is born
Title
Metabolic analysis of maternal urine
Description
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.
Time Frame
4-6 weeks after the baby is born
Title
Bacteria analysis of breast milk
Description
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.
Time Frame
4-6 weeks after the baby is born
Title
Bacteria analysis of infant feces
Description
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.
Time Frame
4-6 weeks after the baby is born
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Those who are 20 years old and pregnant
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Shiang Wu, Professor
Phone
23123456
Ext
65043
Email
mingshaing@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Shiang Wu, Doctor
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
State/Province
Zhongzheng District
ZIP/Postal Code
100225
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Shiang Wu, Professor
Phone
23123456
Ext
65043
Email
mingshaing@ntu.edu.tw
12. IPD Sharing Statement
Learn more about this trial
Use Babyguard® Breast Milk Probiotics to Verify the Authenticity of the Gut-Breast Axis Hypothesis
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