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

Respiratory Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05670678
• Other study ID #: 22-SM-11-A2-001
• Status: Completed
• Start date: December 19, 2022
• Est. completion date: May 17, 2023

Study information

• Verified date: February 2024
• Source: a2 Milk Company Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 17, 2023
• Est. primary completion date: May 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 3 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Diarrheal Disease
• Infections
• Respiratory Infection
• Respiratory Tract Infections

Intervention

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

Locations

Country	Name	City	State
China	Nan Quan Community Hospital	Jinhua	Zhejiang
China	Qiu Bin Community Hospital	Jinhua	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
a2 Milk Company Ltd.	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (5)

Boehm G, Lidestri M, Casetta P, Jelinek J, Negretti F, Stahl B, Marini A. Supplementation of a bovine milk formula with an oligosaccharide mixture increases counts of faecal bifidobacteria in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2002 May;86(3):F178-81. doi: 10.1136/fn.86.3.f178. — View Citation

Cheng JB, Wang JQ, Bu DP, Liu GL, Zhang CG, Wei HY, Zhou LY, Wang JZ. Factors affecting the lactoferrin concentration in bovine milk. J Dairy Sci. 2008 Mar;91(3):970-6. doi: 10.3168/jds.2007-0689. — View Citation

Gibson GR, Roberfroid MB. Dietary modulation of the human colonic microbiota: introducing the concept of prebiotics. J Nutr. 1995 Jun;125(6):1401-12. doi: 10.1093/jn/125.6.1401. — View Citation

Leyer GJ, Li S, Mubasher ME, Reifer C, Ouwehand AC. Probiotic effects on cold and influenza-like symptom incidence and duration in children. Pediatrics. 2009 Aug;124(2):e172-9. doi: 10.1542/peds.2008-2666. Epub 2009 Jul 27. — View Citation

Li F, Jin X, Liu B, Zhuang W, Scalabrin D. Follow-up formula consumption in 3- to 4-year-olds and respiratory infections: an RCT. Pediatrics. 2014 Jun;133(6):e1533-40. doi: 10.1542/peds.2013-3598. Epub 2014 May 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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