Skip to main content
OpenTrials
Completed

NCT Number: NCT05670678

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

2 year–3 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nan Quan Community Hospital, Jinhua, Zhejiang, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

a2 growing up stage 3 formula puls lactoferrin supplement

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

Dietary Supplement

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

Primary outcomes

  1. Change of frequency of acute respiratory infection (ARI) and/or diarrheal disease

    Time frame: baseline day 0, day 90

    Change of frequency of acute respiratory infection (ARI) and/or diarrheal disease from baseline to 3 months

Secondary outcomes

  1. Duration of acute respiratory infections(ARI) and/or diarrheal disease

    Time frame: 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

  2. Number of days of antibiotics treated

    Time frame: 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

  3. Amount of study formula consumed

    Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90

    Amount of study formula consumed (in grams)

  4. Changes in stool pattern

    Time frame: 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

  5. Cost of medical treatment

    Time frame: 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

Sponsors and collaborators

Lead sponsor

a2 Milk Company Ltd.

Industry

Collaborators

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 4, 2023
Registry last updated
Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.