Respiratory InfectionNCT05670678
Improved Respiratory Infection by Consuming Lactoferrin Fortified a2 Growing up Formula in Children of 2 to 3 Year Old
An observational study of Respiratory Infection and Diarrheal Disease, run by a2 Milk Company Ltd. at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 2 to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Infection, Diarrheal Disease
- What is being tested?
- a2 growing up stage 3 formula puls lactoferrin supplement and Enfinitas growing up stage 3 formula
- How many people
- 200 participants
- Where
- 2 sitesChina
- Study dates
- 19 Dec 2022to 17 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Full term born children who are 2-3 years old and consume Milk or milk-based beverage regularly
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Nan Quan Community Hospital
Jinhua, Zhejiang
Qiu Bin Community Hospital
Jinhua, Zhejiang
About this study
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
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
Read the 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.
- Conditions
- Respiratory Infection, Diarrheal Disease
- Being tested
- a2 growing up stage 3 formula puls lactoferrin supplement, Enfinitas growing up stage 3 formula
- Keywords
- growing up stage 3 formula, lactoferrin, acute respiratory infection, diarrheal disease
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a2 growing up stage 3 formula puls lactoferrin supplementDietary 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 formulaDietary supplement
The participants in this group will consume 4 scoops (10g/scoop) of the assigned formula each time, and 3 times per day
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Enfinitas growing up stage 3 formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline day 0, day 90
Secondary outcomes (5)
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
Measured: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
Number of days of antibiotics treated
Number of days of antibiotics treated for each visit interval
Measured: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
Amount of study formula consumed
Amount of study formula consumed (in grams)
Measured: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
Changes in stool pattern
Average number of bowel movements per week and stool consistency
Measured: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
Cost of medical treatment
Cost of medical treatment in RMB yuan for each visit interval
Measured: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start19 Dec 2022
- Primary completion17 May 2023
- Study completion17 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Respiratory InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- a2 Milk Company Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaoyang Sheng, MD, Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670678
- Sponsor's protocol ID
- 22-SM-11-A2-001
- Status last verified
- Feb 2024
- First submitted
- 20 Dec 2022
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24843061Leyer 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.
PubMed 19651563Gibson 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.
PubMed 7782892Boehm 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.
PubMed 11978748Cheng 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.
PubMed 18292252Yu W, Wang W, Sheng X. Effect of A1 protein-free formula versus conventional formula on acute respiratory infections and diarrhea in toddlers: A Randomized Controlled Trial. J Pediatr Gastroenterol Nutr. 2025 Apr;80(4):705-713. doi: 10.1002/jpn3.12473. Epub 2025 Feb 3.
PubMed 39895612
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05670678
- Acronym / sponsor ID
- 22-SM-11-A2-001
- Conditions
- Respiratory Infection, Diarrheal Disease
- Keywords
- growing up stage 3 formula, lactoferrin, acute respiratory infection, diarrheal disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- a2 Milk Company Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- 17 May 2023 (actual)
- Study completion
- 17 May 2023 (actual)
- First posted
- 4 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| a2 growing up stage 3 formula puls lactoferrin supplement | – | Dietary Supplement: a2 growing up stage 3 formula puls lactoferrin supplementper 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 |
| Enfinitas growing up stage 3 formula | – | Dietary Supplement: Enfinitas growing up stage 3 formulaper 100g serving * Lactoferrin 330 mg * Galactooligosaccharides (GOS) at 1.58 mg * β-Glucan 22 mg * DHA 0.4 |
Who may qualify
- Ages
- 2 to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Full term born children who are 2-3 years old and consume Milk or milk-based beverage regularly
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a2 growing up stage 3 formula puls lactoferrin supplementThe 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 | a2 growing up stage 3 formula puls lactoferrin supplement |
| Enfinitas growing up stage 3 formulaThe participants in this group will consume 4 scoops (10g/scoop) of the assigned formula each time, and 3 times per day | Dietary supplement | Enfinitas growing up stage 3 formula |
Primary outcome
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
5 secondary outcomes
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 of antibiotics treated
Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
Amount of study formula consumed
Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
Changes in stool pattern
Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
Cost of medical treatment
Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Background: PubMed 24843061Li 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.
- Background: PubMed 19651563Leyer 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.
- Background: PubMed 7782892Gibson 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.
- Background: PubMed 11978748Boehm 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.
- Background: PubMed 18292252Cheng 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.
- Derived from this study: PubMed 39895612Yu W, Wang W, Sheng X. Effect of A1 protein-free formula versus conventional formula on acute respiratory infections and diarrhea in toddlers: A Randomized Controlled Trial. J Pediatr Gastroenterol Nutr. 2025 Apr;80(4):705-713. doi: 10.1002/jpn3.12473. Epub 2025 Feb 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoyang Sheng, MD principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Infection and Diarrheal Disease, run by a2 Milk Company Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of frequency of acute respiratory infection (ARI) and/or diarrheal disease (time frame: baseline day 0, day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05670678, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.