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CompletedNCT04672889Updated Jan 10, 2025

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

An interventional study of Placebo and Babyguard® Breast Milk Probiotics in Intestinal Bacteria Flora Disturbance, sponsored by TCI Co., Ltd.. Completed at 1 site in Taiwan. Open to female participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-10.

Sponsored by TCI Co., Ltd. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
Female
01

Study 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

Read the 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.

02

Conditions studied

  • Intestinal Bacteria Flora Disturbance

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03

In context

Dysbiosis

186 studies on the registry are indexed under Dysbiosis; 59 are open to participants now.

This study's enrollment of 30 is below the median of 60 across 134 interventional studies indexed under Dysbiosis.

Browse Dysbiosis studies →

Lead sponsor

TCI Co., Ltd. is the lead sponsor of 60 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
Female
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
30 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    consume 1 sachet per day for 1 months

    Dietary Supplement: Placebo

  • Experimental
    Babyguard® Breast Milk Probiotics

    consume 1 sachet per day for 1 months

    Dietary Supplement: Babyguard® Breast Milk Probiotics

Interventions

  • Dietary supplementPlacebo

    consume 1 sachet per day for 1 months

  • Dietary supplementBabyguard® Breast Milk Probiotics

    consume 1 sachet per day for 1 months

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4-6 weeks after the baby is born

  2. Group. B Streptococcus (GBS) screening

    Use sterile cotton sticks for vaginal samples, and then perform Group. B Streptococcus (GBS) screening

    Time frame: 35-37 weeks of pregnancy

  3. 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

    Time frame: 4-6 weeks after the baby is born

  4. 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.

    Time frame: 4-6 weeks after the baby is born

  5. 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.

    Time frame: 4-6 weeks after the baby is born

  6. 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.

    Time frame: 4-6 weeks after the baby is born

07

Study locations

1 site
  • National Taiwan University Hospital
    Taipei, Zhongzheng District 100225, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04672889
Lead sponsor
TCI Co., Ltd.
Responsible party
Sponsor
First posted
Dec 17, 2020
Start date
Nov 1, 2021
Primary completion
Sep 30, 2024
Completion
Nov 30, 2024
Last update
Jan 10, 2025

Study contacts

Ming Shiang Wu, Doctor
principal investigator · National Taiwan University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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