New Stage 1 Formula on Gut Comfort and Gut Health

Phase 4

Completed

Conditions: Health Behavior

Interventions: Dietary Supplement: Oral intake of Feihe New Formula
Dietary Supplement: Oral intake of Feihe Stage 1 Formula
Dietary Supplement: Breast Feeding

Registration Number: NCT02406937

Lead Sponsor: Heilongjiang Feihe Dairy Co. Ltd.

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：

1. Efficacy on easy digestion;

2. Changes on SCFA in feces(Baseline and Endpoint)

3. Improvement on gut microbiome strains(Baseline and Day 21); (bifidobacterium/lactobacillus/clostridium perfringens recommended)

4. Changes on sIgA in feces(Baseline and Endpoint)

5. Improvement on tolerance(comfort) via infant fussy/bloating/abdominal pain/milk regurgitation/sleeping time;

6. Incidence of eczema and duration;

7. Infants growth

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 180

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Feihe New Formula	Oral intake of Feihe New Formula	Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Feihe Stage 1 Formula	Oral intake of Feihe Stage 1 Formula	Oral intake of Feihe stage 1 formula
Breast Feeding	Breast Feeding	Oral intake of breast milk

Primary Outcome Measures

Name	Time	Method
Stool Frequency	Baseline, Week 4, Week 8, Week 12	Average daily stool frequency during the measurement week

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Gastrointestinal Symptoms	Weekly (Baseline to Day 84)	Number of participants with symptom of bloating and abdominal pain
Stool Consistency	Baseline, Week 4, Week 8, Week 12	Average Bristol Score during the measurement week. The seven types of stool are: 1. = Separate hard lumps, like nuts (difficult to pass) 2. = Sausage-shaped but lumpy 3. = Like a sausage but with cracks in its surface 4. = Like a sausage or snake, smooth and soft 5. = Soft blobs with clear-cut edges (passed easily) 6. = Fluffy pieces with ragged edges; a mushy stool 7. = 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.
Crying Time	Baseline, Week 4, Week 8, Week 12	Questionnaire recorded by parents. Average crying time per day during the measurement week.
Fecal Concentration of Short Chain Fatty Acid	Baseline, Day 21	fecal concentration of acetate, propionate and butyrate acid
Body Length	Baseline, Day 28, Day 56, Day 84	Body length
Number of Participants With Eczema	Throughout the study period (84 days)
Fecal Laboratory Detection for sIgA	Baseline, Day 84
Fecal Bacterium Concentration	Baseline, Day 21	bifidobacterium, lactobacillus, clostridium perfringens
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	Baseline, Week 4, Week 8, Week 12	Questionnaire recorded by parents. Average daily frequency of milk regurgitation during the measurement week.
Milk Feeding Quantity	Baseline, Week 4, Week 8, Week 12	Questionnaire recorded by parents. Average quantity of milk feeding per day during the measurement week.
Sleeping Time	Baseline, Week 4, Week 8, Week 12	Questionnaire recorded by parents. Average sleeping time per day during the measurement week.
Body Mass Index (BMI)	Baseline, Week 4, Week 8, Week 12	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).