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The Impact of Infant Formula With Probiotics on Infants Health

NCT03993301 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2023-07-19

No results posted yet for this study

Summary

The trial will be divided into three groups, the experimental group: (I) probiotic A formula, (II) probiotic B formula; control group: (III) regular formula (Youluck infant formula). Inclusion criteria included: (1) the normal spontaneous delivery (NSD) full-term health infants (≧37 weeks) and birth weight more than 2500 grams and (2) subjects who are expected to breastfeed are eligible for the trial after informed consent form is signed by the parents. Exclusion criteria included: infants with chronic diarrhea, hemangioma, cerebral hemorrhage, severe asphyxia (stage III), fetal chromosomal abnormalities, cyanotic congenital heart disease, intestinal hypoplasia or abnormal immune function after birth, liver failure, breastfeeding within two months after birth, taking other probiotic products within two weeks after birth, treatment with antibiotics during acute infection and diagnosis of allergies, gastroenteritis, respiratory infections will be excluded. The study will be conducted for half a year, 5 cans of Youluck infant formula are provided for each subject during the test period. The Youluck infant formula is sponsored free of charge by glac biotech Co., Ltd. During hospitalization, the infant will be feed by same group of experienced nurses and all infants will be monitored for adverse conditions such as vomiting, diarrhea or bloating every day.

Conditions

  • Probiotics Infant Formula
  • Infants Health

Interventions

OTHER

Probiotic A formula

Feeding baby two meals a day with Infant formula with probiotics (10\^8 colony-forming unit per day) at least.

OTHER

Probiotic B formula

Feeding baby two meals a day with Infant formula with probiotics (10\^8 colony-forming unit per day) at least.

OTHER

Regular formula

Feeding baby two meals a day with regular formula at least.

Sponsors & Collaborators

  • Glac Biotech Co., Ltd

    collaborator INDUSTRY

  • China Medical University Hospital

    lead OTHER

Principal Investigators

  • Hung-Chih Lin · China Medical University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-11
Primary Completion
2020-06-16
Completion
2022-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03993301 on ClinicalTrials.gov