Trial Outcomes & Findings for New Stage 1 Formula on Gut Comfort and Gut Health (NCT NCT02406937)
NCT ID: NCT02406937
Last Updated: 2016-10-10
Results Overview
Average daily stool frequency during the measurement week
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
180 participants
Primary outcome timeframe
Baseline, Week 4, Week 8, Week 12
Results posted on
2016-10-10
Participant Flow
Participant milestones
| Measure |
Feihe New Formula
Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Oral intake: Oral intake
|
Feihe Formula
Oral intake of Feihe stage 1 formula
Oral intake: Oral intake
|
Breast Feeding
Oral intake of breast milk
Oral intake: Oral intake
|
|---|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
60
|
|
Overall Study
COMPLETED
|
59
|
59
|
58
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
New Stage 1 Formula on Gut Comfort and Gut Health
Baseline characteristics by cohort
| Measure |
Feihe New Formula
n=59 Participants
Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Oral intake: Oral intake
|
Feihe Formula
n=59 Participants
Oral intake of Feihe stage 1 formula
Oral intake: Oral intake
|
Breast Feeding
n=58 Participants
Oral intake of breast milk
Oral intake: Oral intake
|
Total
n=176 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.5 Days
STANDARD_DEVIATION 18.3 • n=5 Participants
|
58.4 Days
STANDARD_DEVIATION 17.0 • n=7 Participants
|
59.8 Days
STANDARD_DEVIATION 20.5 • n=5 Participants
|
57.9 Days
STANDARD_DEVIATION 18.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
|
Region of Enrollment
China
|
59 participants
n=5 Participants
|
59 participants
n=7 Participants
|
58 participants
n=5 Participants
|
176 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12Average daily stool frequency during the measurement week
Outcome measures
| Measure |
Feihe New Formula
n=59 Participants
Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Oral intake: Oral intake
|
Feihe Formula
n=59 Participants
Oral intake of Feihe stage 1 formula
Oral intake: Oral intake
|
Breast Feeding
n=58 Participants
Oral intake of breast milk
Oral intake: Oral intake
|
|---|---|---|---|
|
Stool Frequency
Baseline
|
2.2 Times per day
Standard Deviation 1.0
|
2.2 Times per day
Standard Deviation 0.9
|
2.3 Times per day
Standard Deviation 1.0
|
|
Stool Frequency
Week 4
|
1.6 Times per day
Standard Deviation 0.5
|
1.8 Times per day
Standard Deviation 0.6
|
2.1 Times per day
Standard Deviation 0.7
|
|
Stool Frequency
Week 8
|
1.2 Times per day
Standard Deviation 0.3
|
1.6 Times per day
Standard Deviation 0.5
|
1.5 Times per day
Standard Deviation 0.5
|
|
Stool Frequency
Week 12
|
1.0 Times per day
Standard Deviation 0.3
|
1.5 Times per day
Standard Deviation 0.4
|
1.6 Times per day
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Weekly (Baseline to Day 84)Number of participants with symptom of bloating and abdominal pain
Outcome measures
| Measure |
Feihe New Formula
n=59 Participants
Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Oral intake: Oral intake
|
Feihe Formula
n=59 Participants
Oral intake of Feihe stage 1 formula
Oral intake: Oral intake
|
Breast Feeding
n=58 Participants
Oral intake of breast milk
Oral intake: Oral intake
|
|---|---|---|---|
|
Number of Participants With Gastrointestinal Symptoms
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12Average 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.
Outcome measures
| Measure |
Feihe New Formula
n=59 Participants
Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Oral intake: Oral intake
|
Feihe Formula
n=59 Participants
Oral intake of Feihe stage 1 formula
Oral intake: Oral intake
|
Breast Feeding
n=58 Participants
Oral intake of breast milk
Oral intake: Oral intake
|
|---|---|---|---|
|
Stool Consistency
Baseline
|
3.61 units on a scale
Standard Deviation 0.63
|
3.74 units on a scale
Standard Deviation 0.55
|
3.76 units on a scale
Standard Deviation 0.90
|
|
Stool Consistency
Week 4
|
3.19 units on a scale
Standard Deviation 0.63
|
3.59 units on a scale
Standard Deviation 0.50
|
3.73 units on a scale
Standard Deviation 0.66
|
|
Stool Consistency
Week 8
|
3.09 units on a scale
Standard Deviation 0.44
|
3.38 units on a scale
Standard Deviation 0.38
|
3.50 units on a scale
Standard Deviation 0.51
|
|
Stool Consistency
Week 12
|
3.05 units on a scale
Standard Deviation 0.79
|
3.35 units on a scale
Standard Deviation 0.46
|
3.57 units on a scale
Standard Deviation 0.62
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12Questionnaire recorded by parents. Average crying time per day during the measurement week.
Outcome measures
| Measure |
Feihe New Formula
n=59 Participants
Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Oral intake: Oral intake
|
Feihe Formula
n=59 Participants
Oral intake of Feihe stage 1 formula
Oral intake: Oral intake
|
Breast Feeding
n=58 Participants
Oral intake of breast milk
Oral intake: Oral intake
|
|---|---|---|---|
|
Crying Time
Baseline
|
2.98 minutes/day
Standard Deviation 2.88
|
2.90 minutes/day
Standard Deviation 1.65
|
2.92 minutes/day
Standard Deviation 2.65
|
|
Crying Time
Week 4
|
3.43 minutes/day
Standard Deviation 1.37
|
2.69 minutes/day
Standard Deviation 0.97
|
2.62 minutes/day
Standard Deviation 2.26
|
|
Crying Time
Week 8
|
2.72 minutes/day
Standard Deviation 0.77
|
2.40 minutes/day
Standard Deviation 0.69
|
2.34 minutes/day
Standard Deviation 1.02
|
|
Crying Time
Week 12
|
2.83 minutes/day
Standard Deviation 0.79
|
2.06 minutes/day
Standard Deviation 0.56
|
2.01 minutes/day
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: Baseline, Day 21fecal concentration of acetate, propionate and butyrate acid
Outcome measures
| Measure |
Feihe New Formula
n=59 Participants
Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Oral intake: Oral intake
|
Feihe Formula
n=59 Participants
Oral intake of Feihe stage 1 formula
Oral intake: Oral intake
|
Breast Feeding
n=58 Participants
Oral intake of breast milk
Oral intake: Oral intake
|
|---|---|---|---|
|
Fecal Concentration of Short Chain Fatty Acid
Baseline acetate acid
|
4.66 mg/g
Standard Deviation 1.31
|
4.75 mg/g
Standard Deviation 1.57
|
4.72 mg/g
Standard Deviation 1.73
|
|
Fecal Concentration of Short Chain Fatty Acid
Baseline propionate acid
|
1.28 mg/g
Standard Deviation 0.51
|
1.27 mg/g
Standard Deviation 0.61
|
1.33 mg/g
Standard Deviation 0.60
|
|
Fecal Concentration of Short Chain Fatty Acid
Baseline butyrate acid
|
0.83 mg/g
Standard Deviation 0.51
|
0.85 mg/g
Standard Deviation 0.46
|
0.81 mg/g
Standard Deviation 0.57
|
|
Fecal Concentration of Short Chain Fatty Acid
Day 21 acetate acid
|
4.14 mg/g
Standard Deviation 1.10
|
4.77 mg/g
Standard Deviation 1.50
|
4.88 mg/g
Standard Deviation 1.93
|
|
Fecal Concentration of Short Chain Fatty Acid
Day 21 propionate acid
|
1.32 mg/g
Standard Deviation 0.52
|
1.35 mg/g
Standard Deviation 0.51
|
1.42 mg/g
Standard Deviation 0.68
|
|
Fecal Concentration of Short Chain Fatty Acid
Day 21 butyrate acid
|
0.84 mg/g
Standard Deviation 0.49
|
0.87 mg/g
Standard Deviation 0.47
|
0.86 mg/g
Standard Deviation 0.61
|
SECONDARY outcome
Timeframe: Baseline, Day 28, Day 56, Day 84Body length
Outcome measures
| Measure |
Feihe New Formula
n=59 Participants
Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Oral intake: Oral intake
|
Feihe Formula
n=59 Participants
Oral intake of Feihe stage 1 formula
Oral intake: Oral intake
|
Breast Feeding
n=58 Participants
Oral intake of breast milk
Oral intake: Oral intake
|
|---|---|---|---|
|
Body Length
Baseline
|
56.9 cm
Standard Deviation 2.3
|
57.7 cm
Standard Deviation 2.4
|
57.8 cm
Standard Deviation 2.8
|
|
Body Length
Day 28
|
60.3 cm
Standard Deviation 2.2
|
60.8 cm
Standard Deviation 2.2
|
61.1 cm
Standard Deviation 2.7
|
|
Body Length
Day 56
|
62.6 cm
Standard Deviation 2.0
|
63.2 cm
Standard Deviation 2.3
|
63.5 cm
Standard Deviation 2.3
|
|
Body Length
Day 84
|
64.6 cm
Standard Deviation 2.2
|
64.8 cm
Standard Deviation 2.4
|
65.4 cm
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Throughout the study period (84 days)Outcome measures
| Measure |
Feihe New Formula
n=59 Participants
Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Oral intake: Oral intake
|
Feihe Formula
n=59 Participants
Oral intake of Feihe stage 1 formula
Oral intake: Oral intake
|
Breast Feeding
n=58 Participants
Oral intake of breast milk
Oral intake: Oral intake
|
|---|---|---|---|
|
Number of Participants With Eczema
|
15 participants
|
9 participants
|
8 participants
|
SECONDARY outcome
Timeframe: Baseline, Day 84Outcome measures
| Measure |
Feihe New Formula
n=59 Participants
Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Oral intake: Oral intake
|
Feihe Formula
n=59 Participants
Oral intake of Feihe stage 1 formula
Oral intake: Oral intake
|
Breast Feeding
n=58 Participants
Oral intake of breast milk
Oral intake: Oral intake
|
|---|---|---|---|
|
Fecal Laboratory Detection for sIgA
Baseline
|
53.8 ug/ml
Standard Deviation 19.5
|
53.0 ug/ml
Standard Deviation 20.7
|
55.5 ug/ml
Standard Deviation 20.3
|
|
Fecal Laboratory Detection for sIgA
Day 84
|
55.3 ug/ml
Standard Deviation 12.9
|
62.7 ug/ml
Standard Deviation 11.8
|
65.9 ug/ml
Standard Deviation 10.8
|
SECONDARY outcome
Timeframe: Baseline, Day 21bifidobacterium, lactobacillus, clostridium perfringens
Outcome measures
| Measure |
Feihe New Formula
n=59 Participants
Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Oral intake: Oral intake
|
Feihe Formula
n=59 Participants
Oral intake of Feihe stage 1 formula
Oral intake: Oral intake
|
Breast Feeding
n=58 Participants
Oral intake of breast milk
Oral intake: Oral intake
|
|---|---|---|---|
|
Fecal Bacterium Concentration
Baseline bifidobacterium
|
7.56 log (colony forming units)
Standard Deviation 0.76
|
7.55 log (colony forming units)
Standard Deviation 0.71
|
7.58 log (colony forming units)
Standard Deviation 0.75
|
|
Fecal Bacterium Concentration
Baseline lactobacillus
|
6.61 log (colony forming units)
Standard Deviation 0.86
|
6.58 log (colony forming units)
Standard Deviation 0.83
|
6.63 log (colony forming units)
Standard Deviation 0.78
|
|
Fecal Bacterium Concentration
Baseline clostridium perfringens
|
4.69 log (colony forming units)
Standard Deviation 1.28
|
4.73 log (colony forming units)
Standard Deviation 1.20
|
4.64 log (colony forming units)
Standard Deviation 1.20
|
|
Fecal Bacterium Concentration
Day 21 bifidobacterium
|
7.51 log (colony forming units)
Standard Deviation 0.55
|
7.67 log (colony forming units)
Standard Deviation 0.53
|
7.71 log (colony forming units)
Standard Deviation 0.65
|
|
Fecal Bacterium Concentration
Day 21 lactobacillus
|
6.65 log (colony forming units)
Standard Deviation 0.95
|
6.78 log (colony forming units)
Standard Deviation 0.98
|
6.80 log (colony forming units)
Standard Deviation 0.82
|
|
Fecal Bacterium Concentration
Day 21 clostridium perfringens
|
4.73 log (colony forming units)
Standard Deviation 1.26
|
4.57 log (colony forming units)
Standard Deviation 1.41
|
4.51 log (colony forming units)
Standard Deviation 1.51
|
SECONDARY outcome
Timeframe: Throughout the study period (84 days)Outcome measures
| Measure |
Feihe New Formula
n=59 Participants
Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Oral intake: Oral intake
|
Feihe Formula
n=59 Participants
Oral intake of Feihe stage 1 formula
Oral intake: Oral intake
|
Breast Feeding
n=58 Participants
Oral intake of breast milk
Oral intake: Oral intake
|
|---|---|---|---|
|
Eczema Duration
|
62.1 Days
Standard Deviation 15.0
|
45.2 Days
Standard Deviation 21.1
|
38.6 Days
Standard Deviation 17.6
|
SECONDARY outcome
Timeframe: Baseline, Day 28, Day 56, Day 84Outcome measures
| Measure |
Feihe New Formula
n=59 Participants
Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Oral intake: Oral intake
|
Feihe Formula
n=59 Participants
Oral intake of Feihe stage 1 formula
Oral intake: Oral intake
|
Breast Feeding
n=58 Participants
Oral intake of breast milk
Oral intake: Oral intake
|
|---|---|---|---|
|
Body Weight
Baseline
|
5191.5 g
Standard Deviation 715.2
|
5291.5 g
Standard Deviation 738.9
|
5462.1 g
Standard Deviation 1040.0
|
|
Body Weight
Day 28
|
6142.4 g
Standard Deviation 678.3
|
6251.7 g
Standard Deviation 747.5
|
6370.7 g
Standard Deviation 912.1
|
|
Body Weight
Day 56
|
6922.9 g
Standard Deviation 701.5
|
6975.4 g
Standard Deviation 712.9
|
7102.6 g
Standard Deviation 842.5
|
|
Body Weight
Day 84
|
7430.5 g
Standard Deviation 650.0
|
7484.1 g
Standard Deviation 699.1
|
7575.0 g
Standard Deviation 775.6
|
SECONDARY outcome
Timeframe: Baseline, Day 28, Day 56, Day 84Outcome measures
| Measure |
Feihe New Formula
n=59 Participants
Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Oral intake: Oral intake
|
Feihe Formula
n=59 Participants
Oral intake of Feihe stage 1 formula
Oral intake: Oral intake
|
Breast Feeding
n=58 Participants
Oral intake of breast milk
Oral intake: Oral intake
|
|---|---|---|---|
|
Head Circumference
Day 56
|
41.1 cm
Standard Deviation 1.0
|
41.4 cm
Standard Deviation 1.1
|
41.5 cm
Standard Deviation 1.2
|
|
Head Circumference
Baseline
|
38.5 cm
Standard Deviation 1.2
|
38.7 cm
Standard Deviation 1.2
|
39.0 cm
Standard Deviation 1.3
|
|
Head Circumference
Day 28
|
39.9 cm
Standard Deviation 1.1
|
40.1 cm
Standard Deviation 1.1
|
40.4 cm
Standard Deviation 1.2
|
|
Head Circumference
Day 84
|
42.1 cm
Standard Deviation 1.0
|
42.4 cm
Standard Deviation 1.0
|
42.4 cm
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline, Day 28, Day 56, Day 84Outcome measures
| Measure |
Feihe New Formula
n=59 Participants
Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Oral intake: Oral intake
|
Feihe Formula
n=59 Participants
Oral intake of Feihe stage 1 formula
Oral intake: Oral intake
|
Breast Feeding
n=58 Participants
Oral intake of breast milk
Oral intake: Oral intake
|
|---|---|---|---|
|
Chest Circumference
Baseline
|
36.9 cm
Standard Deviation 1.2
|
37.2 cm
Standard Deviation 1.1
|
37.3 cm
Standard Deviation 1.3
|
|
Chest Circumference
Day 28
|
38.2 cm
Standard Deviation 1.1
|
38.6 cm
Standard Deviation 1.2
|
38.7 cm
Standard Deviation 1.3
|
|
Chest Circumference
Day 56
|
39.4 cm
Standard Deviation 1.0
|
39.6 cm
Standard Deviation 1.1
|
39.8 cm
Standard Deviation 1.2
|
|
Chest Circumference
Day 84
|
40.5 cm
Standard Deviation 1.0
|
40.6 cm
Standard Deviation 1.0
|
40.9 cm
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12Questionnaire recorded by parents. Average daily frequency of milk regurgitation during the measurement week.
Outcome measures
| Measure |
Feihe New Formula
n=59 Participants
Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Oral intake: Oral intake
|
Feihe Formula
n=59 Participants
Oral intake of Feihe stage 1 formula
Oral intake: Oral intake
|
Breast Feeding
n=58 Participants
Oral intake of breast milk
Oral intake: Oral intake
|
|---|---|---|---|
|
Milk Regurgitation Frequency
Baseline
|
2.68 Times/day
Standard Deviation 1.60
|
2.47 Times/day
Standard Deviation 1.42
|
2.43 Times/day
Standard Deviation 1.74
|
|
Milk Regurgitation Frequency
Week 4
|
2.70 Times/day
Standard Deviation 1.27
|
2.02 Times/day
Standard Deviation 0.89
|
1.89 Times/day
Standard Deviation 1.25
|
|
Milk Regurgitation Frequency
Week 8
|
1.75 Times/day
Standard Deviation 1.21
|
1.25 Times/day
Standard Deviation 0.61
|
1.17 Times/day
Standard Deviation 0.84
|
|
Milk Regurgitation Frequency
Week 12
|
1.05 Times/day
Standard Deviation 0.79
|
0.71 Times/day
Standard Deviation 0.40
|
0.64 Times/day
Standard Deviation 0.60
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12Questionnaire recorded by parents. Average quantity of milk feeding per day during the measurement week.
Outcome measures
| Measure |
Feihe New Formula
n=59 Participants
Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Oral intake: Oral intake
|
Feihe Formula
n=59 Participants
Oral intake of Feihe stage 1 formula
Oral intake: Oral intake
|
Breast Feeding
n=58 Participants
Oral intake of breast milk
Oral intake: Oral intake
|
|---|---|---|---|
|
Milk Feeding Quantity
Baseline
|
732.1 ml/day
Standard Deviation 169.3
|
742.2 ml/day
Standard Deviation 97.6
|
750.7 ml/day
Standard Deviation 119.4
|
|
Milk Feeding Quantity
Week 4
|
928.6 ml/day
Standard Deviation 104.6
|
936.3 ml/day
Standard Deviation 88.3
|
946.0 ml/day
Standard Deviation 98.4
|
|
Milk Feeding Quantity
Week 8
|
1063.3 ml/day
Standard Deviation 107.1
|
1062.0 ml/day
Standard Deviation 98.1
|
1070.2 ml/day
Standard Deviation 83.3
|
|
Milk Feeding Quantity
Week 12
|
1179.0 ml/day
Standard Deviation 101.5
|
1181.8 ml/day
Standard Deviation 95.0
|
1182.9 ml/day
Standard Deviation 69.6
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12Questionnaire recorded by parents. Average sleeping time per day during the measurement week.
Outcome measures
| Measure |
Feihe New Formula
n=59 Participants
Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Oral intake: Oral intake
|
Feihe Formula
n=59 Participants
Oral intake of Feihe stage 1 formula
Oral intake: Oral intake
|
Breast Feeding
n=58 Participants
Oral intake of breast milk
Oral intake: Oral intake
|
|---|---|---|---|
|
Sleeping Time
Week 8
|
16.9 hours/day
Standard Deviation 0.5
|
16.8 hours/day
Standard Deviation 0.5
|
16.9 hours/day
Standard Deviation 0.4
|
|
Sleeping Time
Baseline
|
18.0 hours/day
Standard Deviation 0.8
|
17.8 hours/day
Standard Deviation 0.6
|
17.9 hours/day
Standard Deviation 1.3
|
|
Sleeping Time
Week 4
|
17.6 hours/day
Standard Deviation 0.8
|
17.4 hours/day
Standard Deviation 0.5
|
17.6 hours/day
Standard Deviation 0.9
|
|
Sleeping Time
Week 12
|
16.4 hours/day
Standard Deviation 0.6
|
16.4 hours/day
Standard Deviation 0.5
|
16.5 hours/day
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12BMI 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).
Outcome measures
| Measure |
Feihe New Formula
n=59 Participants
Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Oral intake: Oral intake
|
Feihe Formula
n=59 Participants
Oral intake of Feihe stage 1 formula
Oral intake: Oral intake
|
Breast Feeding
n=58 Participants
Oral intake of breast milk
Oral intake: Oral intake
|
|---|---|---|---|
|
Body Mass Index (BMI)
Baseline
|
15.9 kg/m^2
Standard Deviation 1.3
|
15.8 kg/m^2
Standard Deviation 1.4
|
16.2 kg/m^2
Standard Deviation 1.7
|
|
Body Mass Index (BMI)
Week 4
|
16.9 kg/m^2
Standard Deviation 1.1
|
16.9 kg/m^2
Standard Deviation 1.3
|
17.0 kg/m^2
Standard Deviation 1.4
|
|
Body Mass Index (BMI)
Week 8
|
17.6 kg/m^2
Standard Deviation 1.3
|
17.5 kg/m^2
Standard Deviation 1.2
|
17.6 kg/m^2
Standard Deviation 1.3
|
|
Body Mass Index (BMI)
Week 12
|
17.8 kg/m^2
Standard Deviation 1.3
|
17.8 kg/m^2
Standard Deviation 1.1
|
17.7 kg/m^2
Standard Deviation 1.2
|
Adverse Events
Feihe New Formula
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Feihe Formula
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Breast Feeding
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Charlie Zhang
Sprim (Shanghai) Consulting Co., Ltd.
Phone: +86 (21) 51097272
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place