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OpenTrials
Completed

NCT Number: NCT04672889

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

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Key information

Conditions

Intestinal Bacteria Flora Disturbance

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, Zhongzheng District, 100225, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Dietary Supplement

consume 1 sachet per day for 1 months

Babyguard® Breast Milk Probiotics

Dietary Supplement

consume 1 sachet per day for 1 months

Primary outcomes

  1. Microflora of mother's feces

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

    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.

  2. Group. B Streptococcus (GBS) screening

    Time frame: 35-37 weeks of pregnancy

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

  3. The microflora of maternal blood

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

    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. Metabolic analysis of maternal urine

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

    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.

  5. Bacteria analysis of breast milk

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

    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.

  6. Bacteria analysis of infant feces

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

    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.

Sponsors and collaborators

Lead sponsor

TCI Co., Ltd.

Industry

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 17, 2020
Registry last updated
Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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