New Stage 1 Formula on Gut Comfort and Gut Health
Condition: Health Behavior
Intervention: Oral intake of Feihe New Formula; Oral intake of Feihe Stage 1 Formula; Breast Feeding
Intervention description: Oral intake of Feihe New Formula; Oral intake of Feihe Stage 1 Formula; Oral intake of breast milk
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 180.0
Sex: All
Minimum age: 7 Days
Maximum age: 90 Days
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      180 qualified subjects aged from 7 days to 90 days will be enrolled with the 144 completed in
      study (allowing for a 20% drop-out rate). Subjects will be randomly assigned into 3 groups,
      including breast feeding, commercial and new formula group. Study intervention is 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Infants aged 7-90 days;

          -  Fed by breast milk before enrollment;

          -  Parent or legal guardian fully understand the purpose and requirement, including the
             potential risks and side effects of the study;

          -  Willing to participate in the study and comply all the procedures;

          -  Concent form signed by parents.

        Exclusion Criteria:

          -  Twins, multiple birth, low birth weight children, over birth weight children or early
             birth children with gestational age less than 37 weeks;

          -  Think about the need to exclude C-section delivered infants? It's often the majority
             of births in Chinese tier-1 cities, so it will probably make the study recruitment
             slower, and postpone the study. The microflora of C-section infants in known to be
             different compared to normally born infants. At least, the mode of delivery should be
             noted and calculated into the primary and secondary outcome measurements as a
             potential confounding factor

          -  During pregnancy, the mothers had pregnancy complications or other disease that may
             affect the results;

          -  Having serious diseases that may affect study interventions, such as neonatal sepsis,
             pneumonia (associated with respiratory failure), heart failure and other disease;

          -  Having neonatal diarrhea or acute respiratory infections within 48hours before
             enrollment;

          -  Having potential metabolic diseases, chronic diseases, congenital malformations,
             central nervous system disorders, neuromuscular disorders or diseases affecting bone
             metabolism that may affect growth or the study results;

          -  Having taken any food containing prebiotics or probiotics tithing 15 days of
             enrollment;

          -  Having gluten allergy (celiac disease);

          -  Body weight-to-height Z-value<-3 according to the standard of WHO;

          -  Receiving hormone therapy and intravenous nutrition;

          -  Lactose intolerance or allergic to ingredients of study product;

          -  Have participated in other clinical studies within 3 months prior to the date of
             screening;

          -  Unable to comply the study schedule.