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

T

TCI

Status

Completed

Conditions

Intestinal Bacteria Flora Disturbance

Treatments

Dietary Supplement: Babyguard® Breast Milk Probiotics
Dietary Supplement: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04672889
201703031RINC

Details and patient eligibility

About

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

Full 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.

Enrollment

30 patients

Sex

Female

Ages

20 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
consume 1 sachet per day for 1 months
Treatment:
Dietary Supplement: Placebo
Babyguard® Breast Milk Probiotics
Experimental group
Description:
consume 1 sachet per day for 1 months
Treatment:
Dietary Supplement: Babyguard® Breast Milk Probiotics

Trial contacts and locations

1

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Central trial contact

Ming Shiang Wu, Professor

Data sourced from clinicaltrials.gov

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