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

NCT05670678 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2024-02-29

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER

  • a2 Milk Company Ltd.

    lead INDUSTRY

Principal Investigators

  • Xiaoyang Sheng, MD · Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Eligibility

Min Age
2 Years
Max Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-19
Primary Completion
2023-05-17
Completion
2023-05-17

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05670678 on ClinicalTrials.gov