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The goal of this interventional clinical trial is to test the effectiveness of enhancing immunity in newly born infants fed with Feihe investigational formula product containing Lactoferrin fortified with HMO. The main question it aims to answer is:
- whether the immunity functions of participants in terms of frequency of catching flu and cold in the study product arm is significantly better than participants assigned in the other two arms.
240 qualified participants will be randomized to 3 arms (investigational formula, control formula, and breast-feeding) to consume assigned formula or breast-feeding for 12 months according to protocol. There will be up to 6 site visits arranged for each participant during the study, and all relevant clinical and questionnaire data, including the most important primary outcome - frequency of catching flu and cold for each visit interval, will be captured, recorded and entered to CMTS (Clinical Management Trial System) for statistical analysis and reporting.
Researchers will compare the three arms to validate the assumption that the consumption of Feihe investigational formula product containing Lactoferrin fortified with HMO will improve immunity in newly born infants, along with physical development.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Feihe Investigational Formula | Experimental | Feihe Investigational Formula
|
|
| Control Formula | Active Comparator | Control formula contains comparable macronutrients and micronutrients, but does not contain Lactoferrin fortified with HMO |
|
| Breastfeeding | Other | breastmilk-feeding |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Feihe Investigational Formula | Dietary Supplement | Participants in this arm will receive stage 1 and stage 2 Feihe investigational formulas. At the first (up to) 6 months, they will be fed with stage1 formula, and then switch to stage 2 formula until 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of flu and cold during the study | Frequency of flu and cold that participants caught during the study, which has positive relationship with immunology outcomes. | At the age of 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Weight in grams | The weight measurement (gram) of the participant for each site visit | At the age of 15-28 days and 3, 6, 9, 12 months] |
| Height in cm | The height measurement (cm) of the participant for each site visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Weimin Zhang, MD | China National Center for Food Safety Risk Assessment Beijing, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinhua Nanyuan Community Health Center | Jinhua | Zhejiang | China | |||
| Li Pu Community Hospital |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D007774 | Lactation |
| ID | Term |
|---|---|
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
| D049590 | Postpartum Period |
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Two arms of participants will be assigned masked products (investigational formula and control formula) after randomization, while the participants of breastfeeding arm will not be assigned study products.
| Control Formula | Dietary Supplement | Participants in this arm will receive stage 1 and stage 2 Control formulas. At the first (up to) 6 months, they will be fed with stage1 formula, and then switch to stage 2 formula until 12 months. |
|
| Breastfeeding | Other | Exclusively breastfed for the first 4 months and continue with supplement food without any marketed infant formula. |
|
| At the age of 15-28 days and 3, 6, 9, 12 months |
| Head circumference in cm | The head circumference measurement (cm) of the participant for each site visit | At the age of 15-28 days and 3, 6, 9, 12 months |
| Amount of formula intake in ml | The 24-Hour dietary recall of Formula intake (amount in ml of study formula, any other infant formula or milk consumed) of the participant for each site visit | At the age of 15-28 days and 3, 6, 9, 12 months |
| Stool Characteristics Questionnaire | The frequency of bowel movements and the rating score (0-5) of the stool consistency over the 24-hour period. The rating score of the stool consistency from the stool picture: 0-No bowel movement;
| At the age of 15-28 days and 3, 6 months |
| Medically-confirmed adverse events | The frequency of medically-confirmed adverse events occurred during the study | baseline day to 12 months |
| Jinhua |
| Zhejiang |
| China |
| Qiu Bin Community Hospital | Jinhua | Zhejiang | China |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D010850 | Picornaviridae Infections |