The Impact of Infant Formula With Probiotics on Infants Health
The Impact of Infant Formula With Probiotics on Infants Health
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.
Probiotics were defined as an ''live microorganisms, which, when administered in adequate
 amounts, conferred a health benefit on the host. Before 2005, some animal experiments
 indicated that probiotics could help weight gain. In 2006, there was a team observed the
 growth of infants who received infant formula with probiotics. The study found that infants
 who received infant formula with probiotics for half a year had higher height and weight than
 infants who received regular formula, and the defecation frequency was increased. So far,
 clinical studies had proved that probiotics had an efficacy on gastrointestinal immune
 regulation. Some studies had found that concentrated preparations mixed with various
 probiotics had therapeutic effects on inflammatory bowel diseases. The latest double-blind
 study of infants with acute diarrhoea showed that oral dehydration supplements enriched
 probiotics and zinc could reduce the severity of diarrhoea on day 2 without any side effects.
 Therefore, more and more probiotic clinical studies had suggested that probiotics could be
 used to regulate gastrointestinal related diseases.

 According to statistics, the proportion of atopic dermatitis in infants and children
 worldwide is about 10-20%, and about 30% of toddlers with more than three episodes of
 wheezing bronchitis may develop persistent asthma. Therefore, how to effectively prevent the
 occurrence of allergic diseases was still an urgent goal for infants and young children.
 There is now evidence in mice and humans of an early-life "critical window" in which the
 effects of gut microbial dysbiosis are most influential in human immune development.
 Investigators showed that infants at risk of asthma exhibited transient gut microbial
 dysbiosis during the first 100 days of life. Inoculation of the relatively lower abundance of
 the genus to asthmatic mice ameliorated airway inflammation. These results enhanced the
 potential for future microbe-based diagnostics and therapies, potentially in the form of
 probiotics, to prevent the development of asthma and other related allergic diseases in
 children.

 In addition, respiratory infections were diseases that needed attention during the growth
 phase of infants and young children. The most common treatment for respiratory infections or
 acute otitis media in infants and young children was using antibiotics, but antibiotic
 treatment might lead to antibiotic resistance and intestinal microbial disorders, which might
 promote colonization of pathogens. In recent years, probiotics had attracted more and more
 attention for the prevention of respiratory infections. For example, investigators showed
 that using Bifidobacterium probiotics in children before 2 years old might reduce the
 incidence of respiratory infections.

 Based on the above studies, Investigators will use infant formula with probiotics to infants.
 The study will assess the growth, incidence of allergies, gastroenteritis and respiratory
 infections of infants. This observational study will be conducted at the China Medical
 University Children's Hospital performed a double-blind randomized trial.

 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. After the study is completed, the remaining probiotic milk powder will be subjected to
 high temperature and high pressure for sterilization, and then placed in an infectious
 garbage bag or infective trash can, and destructed by a cleaning company.

 Sample size calculation is based on the literature. The incidence of enteritis, allergic
 disease or respiratory infection in infants is about 30%. Investigators assume that the
 experimental group has a 50% improvement compared with the control group. If investigators
 allow 5% chance of type 1 error (α=0.05) and 10% chance of type 2 error (β=0.1), then the
 required sample size in each group will be 60 people (total 180 infants in three groups).

 The research data will be based on International Business Machines Statistical Product and
 Service Solutions (IBM SPSS) for analytical statistics. Normally distributed data were
 analyzed using Student's t-test two-tailed assay, and non-normally distributed data were
 analyzed using the Wilcoxon signed-rank test. Data were presented as mean ± standard
 deviation (SEM) or median, with P values < 0.05 being considered statistically significant.
Inclusion Criteria:

 1. The normal spontaneous delivery (NSD) full-term health infants (≧37 weeks) and birth
 weight more than 2500 grams.

 2. Subjects who are expected to breastfeed are eligible for the trial after informed
 consent form is signed by the parents.

 Exclusion Criteria:

 1. Chronic diarrhea

 2. Hemangioma

 3. Cerebral hemorrhage

 4. Severe asphyxia (stage III)

 5. Fetal chromosomal abnormalities

 6. Cyanotic congenital heart disease

 7. Intestinal hypoplasia or abnormal immune function after birth.

 8. Liver failure

 9. Breastfeeding within two months after birth.

 10. Taking other probiotic products within two weeks after birth.

 11. Treatment with antibiotics during acute infection and diagnosis of allergies.

 12. Gastroenteritis

 13. Respiratory infections