Improved Respiratory Infection by Consuming Lactoferrin Fortified a2 Growing up Formula in Children of 2 to 3 Year Old

Study Overview
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Brief Summary
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The goal of this observational study is to compare the incidence of ARI and/or diarrheal disease associated with feeding different formulas with and without lactoferrin supplement in children of 2-3 years old. 200 children eligible for the study will be enrolled from two study sites and randomly assigned to two groups (a2 growing up stage 3 formula puls lactoferrin supplement, and Enfinitas growing up stage 3 formula) to feed for 90 days. About 160 children (80 for each group) are expected to finish the study, and data will be collected during the four visits across the study. Researchers will compare the two groups to see if there is significant decrease of the occurrence of diarrheal disease and/or acute respiratory infection for children fed with a2 growing up stage 3 formula puls lactoferrin supplement

Detailed Description
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This study is two arms, opening parallel-designed, observational study. Diarrheal and infectious episodes, including acute upper and lower respiratory infections (ARI), changes in stool patterns, use of systemic antibiotics, adverse events and study formula consumption will be compared in children 2 - 3 years of age who are assigned to receive one of the two following study formulas for a 3-month feeding period: a2 growing up stage 3 formula puls lactoferrin supplement and Enfinitas growingup stage 3 formula. 200 children eligible for the study will be enrolled from two study sites and randomly assigned to two groups to feed for 90 days. About 160 children (80 for each group) are expected to finish the study, and data of primary and secondary outcomes will be collected during the four visits across the study. A sample size of 80 completed per group is needed to achieve a 80% power. The Andersen-Gill model will be used to model the primary outcome (recurrent event of either diarrheal disease or an acute respiratory infection) under the framework of the proportional hazard assumption. For other secondary outcomes such as duration of acute respiratory infections(ARI) and/or diarrheal disease, episodes of systemic antibiotic use,amount of study formula consumed,changes in stool pattern and cost of treatment will also be analyzed.

Official Title
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Improved Respiratory Infection Outcomes Associated With Lactoferrin Fortified a2 Growing up Formula Consumption in Children of 2 to 3 Year Old: a Randomized, Open Label Trial

Conditions
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Respiratory Infection, Diarrheal Disease

Intervention / Treatment
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* Dietary Supplement: a2 growing up stage 3 formula puls lactoferrin supplement
* Dietary Supplement: Enfinitas growing up stage 3 formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Full term born children current aged 2-3 years old Birth weight not less than 2500g (5lb 8oz) Consumes Milk or milk-based beverage regularly before recruitment Informed consent signed Parents or guardians of the infants committ not to participate in interventional clinical research during the intervention Exclusion Criteria: Has a potential risk of metabolic or chronic disease; Fetal malformation; Or present with condition(s) that the investigator believes may affect the infant's ability to be orally fed, the infant's normal growth/development, or the infant's health evaluation. In-take prebiotics or probiotic continuesly 15 days before the recruitment. Growth problems or other protencial risks. Larger-gestational age (LGA) babies born to mothers with gestational diabetes (defined as newborns whose birth weight is above the 90th percentile of average - Treated with antibiotics 7 days before study intervention.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| a2 growing up stage 3 formula puls lactoferrin supplement<br>per 100g serving Lactoferrin 30 mg Galactooligosaccharides (GOS) at 3 g DHA 0.37 Lactoferrin supplement plus: 2.68 ml per serving, 20 mg per 2 ml, 600 mg per bottle | Dietary Supplement: a2 growing up stage 3 formula puls lactoferrin supplement<br>* The participants in this group will consume 4-5 scoops (8.5g/scoop) of the assigned formula each time, and 4 times per day<br>|
| Enfinitas growing up stage 3 formula<br>per 100g serving Lactoferrin 330 mg Galactooligosaccharides (GOS) at 1.58 mg β-Glucan 22 mg DHA 0.4 | Dietary Supplement: Enfinitas growing up stage 3 formula<br>* The participants in this group will consume 4 scoops (10g/scoop) of the assigned formula each time, and 3 times per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of frequency of acute respiratory infection (ARI) and/or diarrheal disease | Change of frequency of acute respiratory infection (ARI) and/or diarrheal disease from baseline to 3 months | baseline day 0, day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of acute respiratory infections(ARI) and/or diarrheal disease | Number of days with acute respiratory infections(ARI) and/or diarrheal disease for each visit | baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90 | 
| Number of days of antibiotics treated | Number of days of antibiotics treated for each visit interval | baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90 | 
| Amount of study formula consumed | Amount of study formula consumed (in grams) | baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90 | 
| Changes in stool pattern | Average number of bowel movements per week and stool consistency | baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90 | 
| Cost of medical treatment | Cost of medical treatment in RMB yuan for each visit interval | baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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growing up stage 3 formula, lactoferrin, acute respiratory infection, diarrheal disease