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

NCT04672889 | Completed

• 1 other identifier: 201703031RINC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Intestinal Bacteria Flora Disturbance

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

consume 1 sachet per day for 1 months

Dietary Supplement: Placebo

Babyguard® Breast Milk Probiotics

EXPERIMENTAL

consume 1 sachet per day for 1 months

Dietary Supplement: Babyguard® Breast Milk Probiotics

Interventions

Placebo DIETARY_SUPPLEMENT

consume 1 sachet per day for 1 months

Placebo

Babyguard® Breast Milk Probiotics DIETARY_SUPPLEMENT

consume 1 sachet per day for 1 months

Babyguard® Breast Milk Probiotics

Eligibility Criteria

• Age: 20 Years - 65 Years
• Gender Eligibility Details: Those who are 20 years old and pregnant
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TCI Co., Ltd.: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Zhongzheng District, 100225, Taiwan

Location

Study Officials

• Ming Shiang Wu, Doctor

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 17, 2020
• Study Start: November 1, 2021
• Primary Completion: September 30, 2024
• Study Completion: November 30, 2024
• Last Updated: January 10, 2025

Record last verified: 2025-01

Locations

TW (1)