Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Primary objective:
1. Improvement on gut health and infant comfort
Secondary objective：
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Feihe New Formula | Experimental | Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients. |
|
| Feihe Stage 1 Formula | Active Comparator | Oral intake of Feihe stage 1 formula |
|
| Breast Feeding | Placebo Comparator | Oral intake of breast milk |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral intake of Feihe New Formula | Dietary Supplement | Oral intake of Feihe New Formula |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Stool Frequency | Average daily stool frequency during the measurement week | Baseline, Week 4, Week 8, Week 12 |
| 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:
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jiancun Pan | Heilongjiang Feihe Dairy Co. Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sprim (Shanghai) Consulting Co., Ltd. | Shanghai | Shanghai Municipality | 200336 | China |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Feihe New Formula | Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients. Oral intake: Oral intake |
| FG001 | Feihe Formula | Oral intake of Feihe stage 1 formula Oral intake: Oral intake |
| FG002 | Breast Feeding | Oral intake of breast milk Oral intake: Oral intake |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Feihe New Formula | Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients. Oral intake: Oral intake |
| BG001 | Feihe Formula | Oral intake of Feihe stage 1 formula Oral intake: Oral intake |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Stool Frequency | Average daily stool frequency during the measurement week | Posted | Mean | Standard Deviation | Times per day | Baseline, Week 4, Week 8, Week 12 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Feihe New Formula | Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients. Oral intake: Oral intake |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Charlie Zhang | Sprim (Shanghai) Consulting Co., Ltd. | +86 (21) 51097272 | charlie.zhang@sprim.cn |
Not provided
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D007774 | Lactation |
| ID | Term |
|---|---|
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
| D049590 | Postpartum Period |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Oral intake of Feihe Stage 1 Formula |
| Dietary Supplement |
Oral intake of Feihe Stage 1 Formula |
|
| Breast Feeding | Dietary Supplement | Oral intake of breast milk |
|
| 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 |
| BG002 | Breast Feeding | Oral intake of breast milk Oral intake: Oral intake |
| BG003 | Total | Total of all reporting groups |
| Days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Participants With Gastrointestinal Symptoms | Number of participants with symptom of bloating and abdominal pain | Posted | Number | participants | Weekly (Baseline to Day 84) |
|
|
|
| Secondary | Stool Consistency | Average Bristol Score during the measurement week. The seven types of stool are:
| Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 4, Week 8, Week 12 |
|
|
|
| Secondary | Crying Time | Questionnaire recorded by parents. Average crying time per day during the measurement week. | Posted | Mean | Standard Deviation | minutes/day | Baseline, Week 4, Week 8, Week 12 |
|
|
|
| Secondary | Fecal Concentration of Short Chain Fatty Acid | fecal concentration of acetate, propionate and butyrate acid | Posted | Mean | Standard Deviation | mg/g | Baseline, Day 21 |
|
|
|
| Secondary | Body Length | Body length | Posted | Mean | Standard Deviation | cm | Baseline, Day 28, Day 56, Day 84 |
|
|
|
| Secondary | Number of Participants With Eczema | Posted | Number | participants | Throughout the study period (84 days) |
|
|
|
| Secondary | Fecal Laboratory Detection for sIgA | Posted | Mean | Standard Deviation | ug/ml | Baseline, Day 84 |
|
|
|
| Secondary | Fecal Bacterium Concentration | bifidobacterium, lactobacillus, clostridium perfringens | Posted | Mean | Standard Deviation | log (colony forming units) | Baseline, Day 21 |
|
|
|
| Secondary | Eczema Duration | Posted | Mean | Standard Deviation | Days | Throughout the study period (84 days) |
|
|
|
| Secondary | Body Weight | Posted | Mean | Standard Deviation | g | Baseline, Day 28, Day 56, Day 84 |
|
|
|
| Secondary | Head Circumference | Posted | Mean | Standard Deviation | cm | Baseline, Day 28, Day 56, Day 84 |
|
|
|
| Secondary | Chest Circumference | Posted | Mean | Standard Deviation | cm | Baseline, Day 28, Day 56, Day 84 |
|
|
|
| Secondary | Milk Regurgitation Frequency | Questionnaire recorded by parents. Average daily frequency of milk regurgitation during the measurement week. | Posted | Mean | Standard Deviation | Times/day | Baseline, Week 4, Week 8, Week 12 |
|
|
|
| Secondary | Milk Feeding Quantity | Questionnaire recorded by parents. Average quantity of milk feeding per day during the measurement week. | Posted | Mean | Standard Deviation | ml/day | Baseline, Week 4, Week 8, Week 12 |
|
|
|
| Secondary | Sleeping Time | Questionnaire recorded by parents. Average sleeping time per day during the measurement week. | Posted | Mean | Standard Deviation | hours/day | Baseline, Week 4, Week 8, Week 12 |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | kg/m^2 | Baseline, Week 4, Week 8, Week 12 |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | Feihe Formula | Oral intake of Feihe stage 1 formula Oral intake: Oral intake | 0 | 60 | 0 | 60 |
| EG002 | Breast Feeding | Oral intake of breast milk Oral intake: Oral intake | 0 | 60 | 0 | 60 |
Not provided
Not provided
|
| Week 8 |
|
| Week 12 |
|
|
| Week 8 |
|
| Week 12 |
|
|
| Baseline butyrate acid |
|
| Day 21 acetate acid |
|
| Day 21 propionate acid |
|
| Day 21 butyrate acid |
|
|
| Day 56 |
|
| Day 84 |
|
|
|
| Baseline clostridium perfringens |
|
| Day 21 bifidobacterium |
|
| Day 21 lactobacillus |
|
| Day 21 clostridium perfringens |
|
|
| Day 56 |
|
| Day 84 |
|
|
| Day 56 |
|
| Day 84 |
|
|
| Day 56 |
|
| Day 84 |
|
|
| Week 8 |
|
| Week 12 |
|
|
| Week 8 |
|
| Week 12 |
|
|
| Week 8 |
|
| Week 12 |
|
|
| Week 8 |
|
| Week 12 |
|