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

NCT05670678 | Completed

• 1 other identifier: 22-SM-11-A2-001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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

Conditions

Respiratory Infection; Diarrheal Disease

Keywords

growing up stage 3 formula; lactoferrin; acute respiratory infection; diarrheal disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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 of antibiotics treated

  baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90

• Amount of study formula consumed

  baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90

• Changes in stool pattern

  baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90

• Cost of medical treatment

  baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90

Study Arms (2)

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

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

Interventions

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

a2 growing up stage 3 formula puls lactoferrin supplement

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

Enfinitas growing up stage 3 formula

Eligibility Criteria

• Age: 2 Years - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Full term born children who are 2-3 years old and consume Milk or milk-based beverage regularly

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• a2 Milk Company Ltd.: lead
• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (2)

Nan Quan Community Hospital

Jinhua, Zhejiang, China

Location

Qiu Bin Community Hospital

Jinhua, Zhejiang, China

Location

Related Publications (5)

• 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.

  PMID: 24843061 BACKGROUND

• 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.

  PMID: 19651563 BACKGROUND

• 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.

  PMID: 7782892 BACKGROUND

• 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.

  PMID: 11978748 BACKGROUND

• 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.

  PMID: 18292252 BACKGROUND

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Xiaoyang Sheng, MD

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 4, 2023
• Study Start: December 19, 2022
• Primary Completion: May 17, 2023
• Study Completion: May 17, 2023
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)