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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04672889
Enrollment
30
Registered
2020-12-17
Start date
2021-11-01
Completion date
2024-11-30
Last updated
2025-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intestinal Bacteria Flora Disturbance

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.

Interventions

DIETARY_SUPPLEMENTPlacebo

consume 1 sachet per day for 1 months

DIETARY_SUPPLEMENTBabyguard® Breast Milk Probiotics

consume 1 sachet per day for 1 months

Sponsors

TCI Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Microflora of mother's feces4-6 weeks after the baby is bornCollect 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) screening35-37 weeks of pregnancyUse sterile cotton sticks for vaginal samples, and then perform Group. B Streptococcus (GBS) screening
The microflora of maternal blood4-6 weeks after the baby is bornUse 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 urine4-6 weeks after the baby is bornCollect 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 milk4-6 weeks after the baby is bornCollect 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 feces4-6 weeks after the baby is bornCollect 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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026