New Stage 1 Formula on Gut Comfort and Gut Health

Study Overview
=================
Brief 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.

Detailed Description
-----------------
Primary objective: 1. Improvement on gut health and infant comfort Secondary objective： Efficacy on easy digestion; Changes on SCFA in feces(Baseline and Endpoint) Improvement on gut microbiome strains(Baseline and Day 21); (bifidobacterium/lactobacillus/clostridium perfringens recommended) Changes on sIgA in feces(Baseline and Endpoint) Improvement on tolerance(comfort) via infant fussy/bloating/abdominal pain/milk regurgitation/sleeping time; Incidence of eczema and duration; Infants growth

Official Title
-----------------
Efficacy of New Stage 1 Formula on the Improvement of Gut Comfort and Gut Health

Conditions
-----------------
Health Behavior

Intervention / Treatment
-----------------
* Dietary Supplement: Oral intake of Feihe New Formula
* Dietary Supplement: Oral intake of Feihe Stage 1 Formula
* Dietary Supplement: Breast Feeding


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 7 Days
Maximum Age: 90 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Feihe New Formula<br>Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients. | Dietary Supplement: Oral intake of Feihe New Formula<br>* Oral intake of Feihe New Formula<br>|
| Active Comparator: Feihe Stage 1 Formula<br>Oral intake of Feihe stage 1 formula | Dietary Supplement: Oral intake of Feihe Stage 1 Formula<br>* Oral intake of Feihe Stage 1 Formula<br>|
| Placebo Comparator: Breast Feeding<br>Oral intake of breast milk | Dietary Supplement: Breast Feeding<br>* Oral intake of breast milk<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool Frequency | Average daily stool frequency during the measurement week | Baseline, Week 4, Week 8, Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Gastrointestinal Symptoms | Number of participants with symptom of bloating and abdominal pain | Weekly (Baseline to Day 84) | 
| Stool Consistency | Average Bristol Score during the measurement week. The seven types of stool are: = Separate hard lumps, like nuts (difficult to pass) = Sausage-shaped but lumpy = Like a sausage but with cracks in its surface = Like a sausage or snake, smooth and soft = Soft blobs with clear-cut edges (passed easily) = Fluffy pieces with ragged edges; a mushy stool = Watery, no solid pieces, entirely liquid Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools (especially the latter), as they are easy to defecate while not containing excess liquid, and 5, 6 and 7 tending towards diarrhoea. | Baseline, Week 4, Week 8, Week 12 | 
| Crying Time | Questionnaire recorded by parents. Average crying time per day during the measurement week. | Baseline, Week 4, Week 8, Week 12 | 
| Fecal Concentration of Short Chain Fatty Acid | fecal concentration of acetate, propionate and butyrate acid | Baseline, Day 21 | 
| Body Length | Body length | Baseline, Day 28, Day 56, Day 84 | 
| Number of Participants With Eczema |  | Throughout the study period (84 days) | 
| Fecal Laboratory Detection for sIgA |  | Baseline, Day 84 | 
| Fecal Bacterium Concentration | bifidobacterium, lactobacillus, clostridium perfringens | Baseline, Day 21 | 
| Eczema Duration |  | Throughout the study period (84 days) | 
| Body Weight |  | Baseline, Day 28, Day 56, Day 84 | 
| Head Circumference |  | Baseline, Day 28, Day 56, Day 84 | 
| Chest Circumference |  | Baseline, Day 28, Day 56, Day 84 | 
| Milk Regurgitation Frequency | Questionnaire recorded by parents. Average daily frequency of milk regurgitation during the measurement week. | Baseline, Week 4, Week 8, Week 12 | 
| Milk Feeding Quantity | Questionnaire recorded by parents. Average quantity of milk feeding per day during the measurement week. | Baseline, Week 4, Week 8, Week 12 | 
| Sleeping Time | Questionnaire recorded by parents. Average sleeping time per day during the measurement week. | Baseline, Week 4, Week 8, Week 12 | 
| Body Mass Index (BMI) | BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m^2 (kilogram per square meter). | Baseline, Week 4, Week 8, Week 12 |