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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-19

Study Completion Date

2023-05-17

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

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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.

Conditions

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Respiratory Infection Diarrheal Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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a2 growing up stage 3 formula puls lactoferrin supplement

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

a2 growing up stage 3 formula puls lactoferrin supplement

Intervention Type DIETARY_SUPPLEMENT

The participants in this group will consume 4-5 scoops (8.5g/scoop) of the assigned formula each time, and 4 times per day

Enfinitas growing up stage 3 formula

per 100g serving

* Lactoferrin 330 mg
* Galactooligosaccharides (GOS) at 1.58 mg
* β-Glucan 22 mg
* DHA 0.4

Enfinitas growing up stage 3 formula

Intervention Type DIETARY_SUPPLEMENT

The participants in this group will consume 4 scoops (10g/scoop) of the assigned formula each time, and 3 times per day

Interventions

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a2 growing up stage 3 formula puls lactoferrin supplement

The participants in this group will consume 4-5 scoops (8.5g/scoop) of the assigned formula each time, and 4 times per day

Intervention Type DIETARY_SUPPLEMENT

Enfinitas growing up stage 3 formula

The participants in this group will consume 4 scoops (10g/scoop) of the assigned formula each time, and 3 times per day

Intervention Type DIETARY_SUPPLEMENT

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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes