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

Sponsor

a2 Milk Company Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05670678

Collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other)

160

Enrollment

Locations

6.5

Anticipated Duration (Months)

Patients Per Site

12.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Respiratory Infection Diarrheal Disease	Dietary Supplement: a2 growing up stage 3 formula puls lactoferrin supplement Dietary Supplement: Enfinitas growing up stage 3 formula

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

160 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 13, 2022

Anticipated Primary Completion Date :

Jun 15, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
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	Dietary Supplement: 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
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	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

Arm

Intervention/Treatment

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

Dietary Supplement: 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

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

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

Outcome Measures

Primary Outcome Measures

Change of frequency of acute respiratory infection (ARI) and/or diarrheal disease [baseline day 0, day 90]
Change of frequency of acute respiratory infection (ARI) and/or diarrheal disease from baseline to 3 months

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 3 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.