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New Stage 1 Formula on Gut Comfort and Gut Health

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02406937
Enrollment
180
Registered
2015-04-02
Start date
2015-01-31
Completion date
2015-08-31
Last updated
2016-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Behavior

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

Interventions

DIETARY_SUPPLEMENTOral intake of Feihe New Formula

Oral intake of Feihe New Formula

DIETARY_SUPPLEMENTOral intake of Feihe Stage 1 Formula

Oral intake of Feihe Stage 1 Formula

DIETARY_SUPPLEMENTBreast Feeding

Oral intake of breast milk

Sponsors

Heilongjiang Feihe Dairy Co. Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
7 Days to 90 Days
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Stool FrequencyBaseline, Week 4, Week 8, Week 12Average daily stool frequency during the measurement week

Secondary

MeasureTime frameDescription
Number of Participants With Gastrointestinal SymptomsWeekly (Baseline to Day 84)Number of participants with symptom of bloating and abdominal pain
Stool ConsistencyBaseline, 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.
Crying TimeBaseline, Week 4, Week 8, Week 12Questionnaire recorded by parents. Average crying time per day during the measurement week.
Fecal Concentration of Short Chain Fatty AcidBaseline, Day 21fecal concentration of acetate, propionate and butyrate acid
Body LengthBaseline, Day 28, Day 56, Day 84Body length
Number of Participants With EczemaThroughout the study period (84 days)—
Fecal Laboratory Detection for sIgABaseline, Day 84—
Fecal Bacterium ConcentrationBaseline, Day 21bifidobacterium, lactobacillus, clostridium perfringens
Eczema DurationThroughout the study period (84 days)—
Body WeightBaseline, Day 28, Day 56, Day 84—
Head CircumferenceBaseline, Day 28, Day 56, Day 84—
Chest CircumferenceBaseline, Day 28, Day 56, Day 84—
Milk Regurgitation FrequencyBaseline, Week 4, Week 8, Week 12Questionnaire recorded by parents. Average daily frequency of milk regurgitation during the measurement week.
Milk Feeding QuantityBaseline, Week 4, Week 8, Week 12Questionnaire recorded by parents. Average quantity of milk feeding per day during the measurement week.
Sleeping TimeBaseline, Week 4, Week 8, Week 12Questionnaire recorded by parents. Average sleeping time per day during the measurement week.
Body Mass Index (BMI)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).

Countries

China

Participant flow

Participants by arm

ArmCount
Feihe New Formula
Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients. Oral intake: Oral intake
59
Feihe Formula
Oral intake of Feihe stage 1 formula Oral intake: Oral intake
59
Breast Feeding
Oral intake of breast milk Oral intake: Oral intake
58
Total176

Baseline characteristics

CharacteristicFeihe New FormulaFeihe FormulaBreast FeedingTotal
Age, Continuous55.5 Days
STANDARD_DEVIATION 18.3
58.4 Days
STANDARD_DEVIATION 17
59.8 Days
STANDARD_DEVIATION 20.5
57.9 Days
STANDARD_DEVIATION 18.6
Region of Enrollment
China
59 participants59 participants58 participants176 participants
Sex: Female, Male
Female
30 Participants29 Participants24 Participants83 Participants
Sex: Female, Male
Male
29 Participants30 Participants34 Participants93 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 600 / 600 / 60
serious
Total, serious adverse events
0 / 600 / 600 / 60

Outcome results

Primary

Stool Frequency

Average daily stool frequency during the measurement week

Time frame: Baseline, Week 4, Week 8, Week 12

ArmMeasureGroupValue (MEAN)Dispersion
Feihe New FormulaStool FrequencyWeek 121.0 Times per dayStandard Deviation 0.3
Feihe New FormulaStool FrequencyWeek 41.6 Times per dayStandard Deviation 0.5
Feihe New FormulaStool FrequencyBaseline2.2 Times per dayStandard Deviation 1
Feihe New FormulaStool FrequencyWeek 81.2 Times per dayStandard Deviation 0.3
Feihe FormulaStool FrequencyWeek 121.5 Times per dayStandard Deviation 0.4
Feihe FormulaStool FrequencyWeek 81.6 Times per dayStandard Deviation 0.5
Feihe FormulaStool FrequencyWeek 41.8 Times per dayStandard Deviation 0.6
Feihe FormulaStool FrequencyBaseline2.2 Times per dayStandard Deviation 0.9
Breast FeedingStool FrequencyWeek 81.5 Times per dayStandard Deviation 0.5
Breast FeedingStool FrequencyWeek 42.1 Times per dayStandard Deviation 0.7
Breast FeedingStool FrequencyBaseline2.3 Times per dayStandard Deviation 1
Breast FeedingStool FrequencyWeek 121.6 Times per dayStandard Deviation 0.4
Secondary

Body Length

Body length

Time frame: Baseline, Day 28, Day 56, Day 84

ArmMeasureGroupValue (MEAN)Dispersion
Feihe New FormulaBody LengthDay 8464.6 cmStandard Deviation 2.2
Feihe New FormulaBody LengthDay 5662.6 cmStandard Deviation 2
Feihe New FormulaBody LengthDay 2860.3 cmStandard Deviation 2.2
Feihe New FormulaBody LengthBaseline56.9 cmStandard Deviation 2.3
Feihe FormulaBody LengthDay 5663.2 cmStandard Deviation 2.3
Feihe FormulaBody LengthDay 2860.8 cmStandard Deviation 2.2
Feihe FormulaBody LengthBaseline57.7 cmStandard Deviation 2.4
Feihe FormulaBody LengthDay 8464.8 cmStandard Deviation 2.4
Breast FeedingBody LengthDay 2861.1 cmStandard Deviation 2.7
Breast FeedingBody LengthBaseline57.8 cmStandard Deviation 2.8
Breast FeedingBody LengthDay 8465.4 cmStandard Deviation 2.3
Breast FeedingBody LengthDay 5663.5 cmStandard Deviation 2.3
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).

Time frame: Baseline, Week 4, Week 8, Week 12

ArmMeasureGroupValue (MEAN)Dispersion
Feihe New FormulaBody Mass Index (BMI)Week 1217.8 kg/m^2Standard Deviation 1.3
Feihe New FormulaBody Mass Index (BMI)Week 817.6 kg/m^2Standard Deviation 1.3
Feihe New FormulaBody Mass Index (BMI)Baseline15.9 kg/m^2Standard Deviation 1.3
Feihe New FormulaBody Mass Index (BMI)Week 416.9 kg/m^2Standard Deviation 1.1
Feihe FormulaBody Mass Index (BMI)Week 416.9 kg/m^2Standard Deviation 1.3
Feihe FormulaBody Mass Index (BMI)Baseline15.8 kg/m^2Standard Deviation 1.4
Feihe FormulaBody Mass Index (BMI)Week 817.5 kg/m^2Standard Deviation 1.2
Feihe FormulaBody Mass Index (BMI)Week 1217.8 kg/m^2Standard Deviation 1.1
Breast FeedingBody Mass Index (BMI)Week 417.0 kg/m^2Standard Deviation 1.4
Breast FeedingBody Mass Index (BMI)Baseline16.2 kg/m^2Standard Deviation 1.7
Breast FeedingBody Mass Index (BMI)Week 1217.7 kg/m^2Standard Deviation 1.2
Breast FeedingBody Mass Index (BMI)Week 817.6 kg/m^2Standard Deviation 1.3
Secondary

Body Weight

Time frame: Baseline, Day 28, Day 56, Day 84

ArmMeasureGroupValue (MEAN)Dispersion
Feihe New FormulaBody WeightBaseline5191.5 gStandard Deviation 715.2
Feihe New FormulaBody WeightDay 286142.4 gStandard Deviation 678.3
Feihe New FormulaBody WeightDay 566922.9 gStandard Deviation 701.5
Feihe New FormulaBody WeightDay 847430.5 gStandard Deviation 650
Feihe FormulaBody WeightDay 847484.1 gStandard Deviation 699.1
Feihe FormulaBody WeightBaseline5291.5 gStandard Deviation 738.9
Feihe FormulaBody WeightDay 566975.4 gStandard Deviation 712.9
Feihe FormulaBody WeightDay 286251.7 gStandard Deviation 747.5
Breast FeedingBody WeightDay 847575.0 gStandard Deviation 775.6
Breast FeedingBody WeightDay 286370.7 gStandard Deviation 912.1
Breast FeedingBody WeightDay 567102.6 gStandard Deviation 842.5
Breast FeedingBody WeightBaseline5462.1 gStandard Deviation 1040
Secondary

Chest Circumference

Time frame: Baseline, Day 28, Day 56, Day 84

ArmMeasureGroupValue (MEAN)Dispersion
Feihe New FormulaChest CircumferenceBaseline36.9 cmStandard Deviation 1.2
Feihe New FormulaChest CircumferenceDay 2838.2 cmStandard Deviation 1.1
Feihe New FormulaChest CircumferenceDay 5639.4 cmStandard Deviation 1
Feihe New FormulaChest CircumferenceDay 8440.5 cmStandard Deviation 1
Feihe FormulaChest CircumferenceDay 8440.6 cmStandard Deviation 1
Feihe FormulaChest CircumferenceBaseline37.2 cmStandard Deviation 1.1
Feihe FormulaChest CircumferenceDay 5639.6 cmStandard Deviation 1.1
Feihe FormulaChest CircumferenceDay 2838.6 cmStandard Deviation 1.2
Breast FeedingChest CircumferenceDay 8440.9 cmStandard Deviation 1
Breast FeedingChest CircumferenceDay 2838.7 cmStandard Deviation 1.3
Breast FeedingChest CircumferenceDay 5639.8 cmStandard Deviation 1.2
Breast FeedingChest CircumferenceBaseline37.3 cmStandard Deviation 1.3
Secondary

Crying Time

Questionnaire recorded by parents. Average crying time per day during the measurement week.

Time frame: Baseline, Week 4, Week 8, Week 12

ArmMeasureGroupValue (MEAN)Dispersion
Feihe New FormulaCrying TimeBaseline2.98 minutes/dayStandard Deviation 2.88
Feihe New FormulaCrying TimeWeek 43.43 minutes/dayStandard Deviation 1.37
Feihe New FormulaCrying TimeWeek 82.72 minutes/dayStandard Deviation 0.77
Feihe New FormulaCrying TimeWeek 122.83 minutes/dayStandard Deviation 0.79
Feihe FormulaCrying TimeWeek 122.06 minutes/dayStandard Deviation 0.56
Feihe FormulaCrying TimeBaseline2.90 minutes/dayStandard Deviation 1.65
Feihe FormulaCrying TimeWeek 82.40 minutes/dayStandard Deviation 0.69
Feihe FormulaCrying TimeWeek 42.69 minutes/dayStandard Deviation 0.97
Breast FeedingCrying TimeWeek 122.01 minutes/dayStandard Deviation 0.48
Breast FeedingCrying TimeWeek 42.62 minutes/dayStandard Deviation 2.26
Breast FeedingCrying TimeWeek 82.34 minutes/dayStandard Deviation 1.02
Breast FeedingCrying TimeBaseline2.92 minutes/dayStandard Deviation 2.65
Secondary

Eczema Duration

Time frame: Throughout the study period (84 days)

ArmMeasureValue (MEAN)Dispersion
Feihe New FormulaEczema Duration62.1 DaysStandard Deviation 15
Feihe FormulaEczema Duration45.2 DaysStandard Deviation 21.1
Breast FeedingEczema Duration38.6 DaysStandard Deviation 17.6
Secondary

Fecal Bacterium Concentration

bifidobacterium, lactobacillus, clostridium perfringens

Time frame: Baseline, Day 21

ArmMeasureGroupValue (MEAN)Dispersion
Feihe New FormulaFecal Bacterium ConcentrationBaseline bifidobacterium7.56 log (colony forming units)Standard Deviation 0.76
Feihe New FormulaFecal Bacterium ConcentrationBaseline lactobacillus6.61 log (colony forming units)Standard Deviation 0.86
Feihe New FormulaFecal Bacterium ConcentrationBaseline clostridium perfringens4.69 log (colony forming units)Standard Deviation 1.28
Feihe New FormulaFecal Bacterium ConcentrationDay 21 bifidobacterium7.51 log (colony forming units)Standard Deviation 0.55
Feihe New FormulaFecal Bacterium ConcentrationDay 21 lactobacillus6.65 log (colony forming units)Standard Deviation 0.95
Feihe New FormulaFecal Bacterium ConcentrationDay 21 clostridium perfringens4.73 log (colony forming units)Standard Deviation 1.26
Feihe FormulaFecal Bacterium ConcentrationDay 21 clostridium perfringens4.57 log (colony forming units)Standard Deviation 1.41
Feihe FormulaFecal Bacterium ConcentrationBaseline bifidobacterium7.55 log (colony forming units)Standard Deviation 0.71
Feihe FormulaFecal Bacterium ConcentrationDay 21 bifidobacterium7.67 log (colony forming units)Standard Deviation 0.53
Feihe FormulaFecal Bacterium ConcentrationDay 21 lactobacillus6.78 log (colony forming units)Standard Deviation 0.98
Feihe FormulaFecal Bacterium ConcentrationBaseline lactobacillus6.58 log (colony forming units)Standard Deviation 0.83
Feihe FormulaFecal Bacterium ConcentrationBaseline clostridium perfringens4.73 log (colony forming units)Standard Deviation 1.2
Breast FeedingFecal Bacterium ConcentrationBaseline lactobacillus6.63 log (colony forming units)Standard Deviation 0.78
Breast FeedingFecal Bacterium ConcentrationBaseline clostridium perfringens4.64 log (colony forming units)Standard Deviation 1.2
Breast FeedingFecal Bacterium ConcentrationDay 21 clostridium perfringens4.51 log (colony forming units)Standard Deviation 1.51
Breast FeedingFecal Bacterium ConcentrationDay 21 bifidobacterium7.71 log (colony forming units)Standard Deviation 0.65
Breast FeedingFecal Bacterium ConcentrationBaseline bifidobacterium7.58 log (colony forming units)Standard Deviation 0.75
Breast FeedingFecal Bacterium ConcentrationDay 21 lactobacillus6.80 log (colony forming units)Standard Deviation 0.82
Secondary

Fecal Concentration of Short Chain Fatty Acid

fecal concentration of acetate, propionate and butyrate acid

Time frame: Baseline, Day 21

ArmMeasureGroupValue (MEAN)Dispersion
Feihe New FormulaFecal Concentration of Short Chain Fatty AcidBaseline acetate acid4.66 mg/gStandard Deviation 1.31
Feihe New FormulaFecal Concentration of Short Chain Fatty AcidBaseline propionate acid1.28 mg/gStandard Deviation 0.51
Feihe New FormulaFecal Concentration of Short Chain Fatty AcidBaseline butyrate acid0.83 mg/gStandard Deviation 0.51
Feihe New FormulaFecal Concentration of Short Chain Fatty AcidDay 21 acetate acid4.14 mg/gStandard Deviation 1.1
Feihe New FormulaFecal Concentration of Short Chain Fatty AcidDay 21 propionate acid1.32 mg/gStandard Deviation 0.52
Feihe New FormulaFecal Concentration of Short Chain Fatty AcidDay 21 butyrate acid0.84 mg/gStandard Deviation 0.49
Feihe FormulaFecal Concentration of Short Chain Fatty AcidDay 21 butyrate acid0.87 mg/gStandard Deviation 0.47
Feihe FormulaFecal Concentration of Short Chain Fatty AcidBaseline acetate acid4.75 mg/gStandard Deviation 1.57
Feihe FormulaFecal Concentration of Short Chain Fatty AcidDay 21 acetate acid4.77 mg/gStandard Deviation 1.5
Feihe FormulaFecal Concentration of Short Chain Fatty AcidDay 21 propionate acid1.35 mg/gStandard Deviation 0.51
Feihe FormulaFecal Concentration of Short Chain Fatty AcidBaseline propionate acid1.27 mg/gStandard Deviation 0.61
Feihe FormulaFecal Concentration of Short Chain Fatty AcidBaseline butyrate acid0.85 mg/gStandard Deviation 0.46
Breast FeedingFecal Concentration of Short Chain Fatty AcidBaseline propionate acid1.33 mg/gStandard Deviation 0.6
Breast FeedingFecal Concentration of Short Chain Fatty AcidBaseline butyrate acid0.81 mg/gStandard Deviation 0.57
Breast FeedingFecal Concentration of Short Chain Fatty AcidDay 21 butyrate acid0.86 mg/gStandard Deviation 0.61
Breast FeedingFecal Concentration of Short Chain Fatty AcidDay 21 acetate acid4.88 mg/gStandard Deviation 1.93
Breast FeedingFecal Concentration of Short Chain Fatty AcidBaseline acetate acid4.72 mg/gStandard Deviation 1.73
Breast FeedingFecal Concentration of Short Chain Fatty AcidDay 21 propionate acid1.42 mg/gStandard Deviation 0.68
Secondary

Fecal Laboratory Detection for sIgA

Time frame: Baseline, Day 84

ArmMeasureGroupValue (MEAN)Dispersion
Feihe New FormulaFecal Laboratory Detection for sIgABaseline53.8 ug/mlStandard Deviation 19.5
Feihe New FormulaFecal Laboratory Detection for sIgADay 8455.3 ug/mlStandard Deviation 12.9
Feihe FormulaFecal Laboratory Detection for sIgABaseline53.0 ug/mlStandard Deviation 20.7
Feihe FormulaFecal Laboratory Detection for sIgADay 8462.7 ug/mlStandard Deviation 11.8
Breast FeedingFecal Laboratory Detection for sIgABaseline55.5 ug/mlStandard Deviation 20.3
Breast FeedingFecal Laboratory Detection for sIgADay 8465.9 ug/mlStandard Deviation 10.8
Secondary

Head Circumference

Time frame: Baseline, Day 28, Day 56, Day 84

ArmMeasureGroupValue (MEAN)Dispersion
Feihe New FormulaHead CircumferenceDay 8442.1 cmStandard Deviation 1
Feihe New FormulaHead CircumferenceDay 2839.9 cmStandard Deviation 1.1
Feihe New FormulaHead CircumferenceDay 5641.1 cmStandard Deviation 1
Feihe New FormulaHead CircumferenceBaseline38.5 cmStandard Deviation 1.2
Feihe FormulaHead CircumferenceDay 2840.1 cmStandard Deviation 1.1
Feihe FormulaHead CircumferenceDay 5641.4 cmStandard Deviation 1.1
Feihe FormulaHead CircumferenceBaseline38.7 cmStandard Deviation 1.2
Feihe FormulaHead CircumferenceDay 8442.4 cmStandard Deviation 1
Breast FeedingHead CircumferenceDay 5641.5 cmStandard Deviation 1.2
Breast FeedingHead CircumferenceDay 2840.4 cmStandard Deviation 1.2
Breast FeedingHead CircumferenceDay 8442.4 cmStandard Deviation 1
Breast FeedingHead CircumferenceBaseline39.0 cmStandard Deviation 1.3
Secondary

Milk Feeding Quantity

Questionnaire recorded by parents. Average quantity of milk feeding per day during the measurement week.

Time frame: Baseline, Week 4, Week 8, Week 12

ArmMeasureGroupValue (MEAN)Dispersion
Feihe New FormulaMilk Feeding QuantityBaseline732.1 ml/dayStandard Deviation 169.3
Feihe New FormulaMilk Feeding QuantityWeek 4928.6 ml/dayStandard Deviation 104.6
Feihe New FormulaMilk Feeding QuantityWeek 81063.3 ml/dayStandard Deviation 107.1
Feihe New FormulaMilk Feeding QuantityWeek 121179.0 ml/dayStandard Deviation 101.5
Feihe FormulaMilk Feeding QuantityWeek 121181.8 ml/dayStandard Deviation 95
Feihe FormulaMilk Feeding QuantityBaseline742.2 ml/dayStandard Deviation 97.6
Feihe FormulaMilk Feeding QuantityWeek 81062.0 ml/dayStandard Deviation 98.1
Feihe FormulaMilk Feeding QuantityWeek 4936.3 ml/dayStandard Deviation 88.3
Breast FeedingMilk Feeding QuantityWeek 121182.9 ml/dayStandard Deviation 69.6
Breast FeedingMilk Feeding QuantityWeek 4946.0 ml/dayStandard Deviation 98.4
Breast FeedingMilk Feeding QuantityWeek 81070.2 ml/dayStandard Deviation 83.3
Breast FeedingMilk Feeding QuantityBaseline750.7 ml/dayStandard Deviation 119.4
Secondary

Milk Regurgitation Frequency

Questionnaire recorded by parents. Average daily frequency of milk regurgitation during the measurement week.

Time frame: Baseline, Week 4, Week 8, Week 12

ArmMeasureGroupValue (MEAN)Dispersion
Feihe New FormulaMilk Regurgitation FrequencyBaseline2.68 Times/dayStandard Deviation 1.6
Feihe New FormulaMilk Regurgitation FrequencyWeek 42.70 Times/dayStandard Deviation 1.27
Feihe New FormulaMilk Regurgitation FrequencyWeek 81.75 Times/dayStandard Deviation 1.21
Feihe New FormulaMilk Regurgitation FrequencyWeek 121.05 Times/dayStandard Deviation 0.79
Feihe FormulaMilk Regurgitation FrequencyWeek 120.71 Times/dayStandard Deviation 0.4
Feihe FormulaMilk Regurgitation FrequencyBaseline2.47 Times/dayStandard Deviation 1.42
Feihe FormulaMilk Regurgitation FrequencyWeek 81.25 Times/dayStandard Deviation 0.61
Feihe FormulaMilk Regurgitation FrequencyWeek 42.02 Times/dayStandard Deviation 0.89
Breast FeedingMilk Regurgitation FrequencyWeek 120.64 Times/dayStandard Deviation 0.6
Breast FeedingMilk Regurgitation FrequencyWeek 41.89 Times/dayStandard Deviation 1.25
Breast FeedingMilk Regurgitation FrequencyWeek 81.17 Times/dayStandard Deviation 0.84
Breast FeedingMilk Regurgitation FrequencyBaseline2.43 Times/dayStandard Deviation 1.74
Secondary

Number of Participants With Eczema

Time frame: Throughout the study period (84 days)

ArmMeasureValue (NUMBER)
Feihe New FormulaNumber of Participants With Eczema15 participants
Feihe FormulaNumber of Participants With Eczema9 participants
Breast FeedingNumber of Participants With Eczema8 participants
Secondary

Number of Participants With Gastrointestinal Symptoms

Number of participants with symptom of bloating and abdominal pain

Time frame: Weekly (Baseline to Day 84)

ArmMeasureValue (NUMBER)
Feihe New FormulaNumber of Participants With Gastrointestinal Symptoms0 participants
Feihe FormulaNumber of Participants With Gastrointestinal Symptoms0 participants
Breast FeedingNumber of Participants With Gastrointestinal Symptoms0 participants
Secondary

Sleeping Time

Questionnaire recorded by parents. Average sleeping time per day during the measurement week.

Time frame: Baseline, Week 4, Week 8, Week 12

ArmMeasureGroupValue (MEAN)Dispersion
Feihe New FormulaSleeping TimeBaseline18.0 hours/dayStandard Deviation 0.8
Feihe New FormulaSleeping TimeWeek 417.6 hours/dayStandard Deviation 0.8
Feihe New FormulaSleeping TimeWeek 816.9 hours/dayStandard Deviation 0.5
Feihe New FormulaSleeping TimeWeek 1216.4 hours/dayStandard Deviation 0.6
Feihe FormulaSleeping TimeWeek 1216.4 hours/dayStandard Deviation 0.5
Feihe FormulaSleeping TimeBaseline17.8 hours/dayStandard Deviation 0.6
Feihe FormulaSleeping TimeWeek 816.8 hours/dayStandard Deviation 0.5
Feihe FormulaSleeping TimeWeek 417.4 hours/dayStandard Deviation 0.5
Breast FeedingSleeping TimeWeek 1216.5 hours/dayStandard Deviation 0.6
Breast FeedingSleeping TimeWeek 417.6 hours/dayStandard Deviation 0.9
Breast FeedingSleeping TimeWeek 816.9 hours/dayStandard Deviation 0.4
Breast FeedingSleeping TimeBaseline17.9 hours/dayStandard Deviation 1.3
Secondary

Stool Consistency

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.

Time frame: Baseline, Week 4, Week 8, Week 12

ArmMeasureGroupValue (MEAN)Dispersion
Feihe New FormulaStool ConsistencyBaseline3.61 units on a scaleStandard Deviation 0.63
Feihe New FormulaStool ConsistencyWeek 43.19 units on a scaleStandard Deviation 0.63
Feihe New FormulaStool ConsistencyWeek 83.09 units on a scaleStandard Deviation 0.44
Feihe New FormulaStool ConsistencyWeek 123.05 units on a scaleStandard Deviation 0.79
Feihe FormulaStool ConsistencyWeek 123.35 units on a scaleStandard Deviation 0.46
Feihe FormulaStool ConsistencyBaseline3.74 units on a scaleStandard Deviation 0.55
Feihe FormulaStool ConsistencyWeek 83.38 units on a scaleStandard Deviation 0.38
Feihe FormulaStool ConsistencyWeek 43.59 units on a scaleStandard Deviation 0.5
Breast FeedingStool ConsistencyWeek 123.57 units on a scaleStandard Deviation 0.62
Breast FeedingStool ConsistencyWeek 43.73 units on a scaleStandard Deviation 0.66
Breast FeedingStool ConsistencyWeek 83.50 units on a scaleStandard Deviation 0.51
Breast FeedingStool ConsistencyBaseline3.76 units on a scaleStandard Deviation 0.9

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026