Healthy VolunteersNCT07882043
Milk Free From A1-Type β-Casein With Human Milk Oligosaccharides on Gut Health, Immunity, Cognitive Development, and Temperament in Toddlers
A study testing a2 toddler milk with HMOs and Conventional toddler milk with HMOs in people with Healthy Volunteers, run by a2 Milk Company Ltd. at 1 site in China.
Trial summary
The aim of the study is to compare the effects of HMOs in A1-type β-casein-free formula on gut health, immunity, inflammation, gut microflora, cognitive development, and temperament compared with HMOs in conventional formula in toddlers aged 24-30 months. Read more about this study
- Who is it for?
- Ages 24 to 30 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- a2 toddler milk with HMOs and Conventional toddler milk with HMOs
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Nov 2026to Dec 2027
- Phase
- Interventional
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 24 to 30 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- (24±3) months of age at enrolment/randomisation Singleton birth Born full-term (37-42 weeks gestation)
- Birth weight of 2500-4500 g
- Habitually consume any cow's milk
- Parent or guardian of toddler agrees not to enrol toddler in another interventional clinical trial while participating in this trial
- Parent or guardian agrees to exclusively feed the toddler the assigned toddler formula, as per the randomisation schedule
Who cannot join
- Toddler with inborn malformation and with hereditary and/or chronic and/or inborn diseases that could interfere with the trial
- Toddlers born after in vitro fertilisation (IVF)
- Diseases that may have jeopardised intrauterine growth
- Toddler whose mother had gestational diabetes, and other metabolic and/or chronic diseases at the time of pregnancy (for example, gestational hypertension, thyroid dysfunction, autoimmune diseases, and pre-existing diabetes mellitus.)
- Known or increased risk of cows' milk protein allergy (i.e., one of the biological parents and/or siblings diagnosed with allergy, asthma, hayfever, etc.)
- Toddlers currently using, or who have ever used, specialty formula or growing-up milk (GUM), such as hypoallergenic, lactose-free, or anti-regurgitation formulas
Show all 13Show fewer
- Toddlers with functional gastrointestinal disorders; e.g., gastroparesis
- Toddlers with an acute infection or gastroenteritis at the time of randomisation
- Evidence of milk/formula intolerance, such as vomiting or poor intake at the time of randomisation
- Participation in another clinical trial
- Investigator uncertainty about the willingness or ability of the parents to comply with the protocol requirements
- Use of antibiotics at the time of screening, or during the 2 weeks before enrolment
- Toddlers with known cognitive or developmental disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shenzhen Maternity & Child Healthcare Hospital
Shenzhen, Guagndong, 518028
Yuting Dai, +86 0755 8286 9849, 1101739264@qq.com
Yongmei Zeng, MD
About this study
Official title: Comparing the Effects of Human Milk Oligosaccharides in A1-Type β-Casein-Free Formula vs Conventional Formula in Children Aged 24-30 Months: A Randomised Trial
The aim of the study is to compare the effects of HMOs in A1-type β-casein-free formula on gut health, immunity, inflammation, gut microflora, cognitive development, and temperament compared with HMOs in conventional formula in toddlers aged 24-30 months.
- Conditions
- Healthy Volunteers
- Being tested
- a2 toddler milk with HMOs, Conventional toddler milk with HMOs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a2 toddler milk with HMOsOther
Participants in this arm will daily consume 8 level scoops of a2 Genesis™ HMO Premium Toddler Milk Drink Stage 3, until study completion. Trial duration is 6 months from baseline to last participant last visit (LPLV).
Conventional toddler milk with HMOsOther
Participants in this arm will daily consume 8 level scoops of conventional S3 milk formula with HMOs, until study completion. Trial duration is 6 months from baseline to last participant last visit (LPLV).
| Study group | Role | What they receive |
|---|---|---|
| a2 toddler milk with HMOs | Active comparator | containing A2 type β-casein only (A1PF) Receives: Other: a2 toddler milk with HMOs |
| Conventional toddler milk with HMOs | Placebo comparator | containing both A1 and A2 type β-caseins (CON) Receives: Other: Conventional toddler milk with HMOs |
What is being measured
The primary outcome is the main question the study is designed to answer.
GI symptoms
Visual analogue scale (VAS) score for gastrointestinal (GI) symptoms
Measured: Visit 1 (baseline)
GI symptoms
Visual analogue scale (VAS) score for gastrointestinal (GI) symptoms
Measured: Visit 2 (5±1 days from baseline)
GI symptoms
Visual analogue scale (VAS) score for gastrointestinal (GI) symptoms
Measured: Visit 3 (90±3 days from baseline)
GI symptoms
Visual analogue scale (VAS) score for gastrointestinal (GI) symptoms
Measured: Visit 4 (180±3 days from baseline)
IgG
Blood IgG levels
Measured: Visit 1 (baseline)
IgG
Blood IgG levels
Measured: Visit 4 (180±3 days from baseline)
Secondary outcomes (31)
hsCRP
Blood hsCRP levels
Measured: Visit 1 (baseline)
hsCRP
Blood hsCRP levels
Measured: Visit 4 (180±3 days from baseline)
IL-4
Blood IL-4 levels
Measured: Visit 1 (baseline)
IL-4
Blood IL-4 levels
Measured: Visit 4 (180±3 days from baseline)
IFN-γ
Blood IFN-γ levels
Measured: Visit 1 (baseline)
IFN-γ
Blood IFN-γ levels
Measured: Visit 4 (180±3 days from baseline)
SCFA
Faecal SCFA levels
Measured: Visit 1 (baseline)
SCFA
Faecal SCFA levels
Measured: Visit 2 (5±1 days from baseline)
SCFA
Faecal SCFA levels
Measured: Visit 3 (90±3 days from baseline)
SCFA
Faecal SCFA levels
Measured: Visit 4 (180±3 days from baseline)
Faecal microflora
Faecal microflora, including species phylogenetic analysis, Alpha diversity, and Beta diversity analysis.
Measured: Visit 1 (baseline)
Faecal microflora
Faecal microflora, including species phylogenetic analysis, Alpha diversity, and Beta diversity analysis.
Measured: Visit 4 (180±3 days from baseline)
sIgA
Salivary sIgA levels
Measured: Visit 1 (baseline)
sIgA
Salivary sIgA levels
Measured: Visit 2 (5±1 days from baseline)
sIgA
Salivary sIgA levels
Measured: Visit 3 (90±3 days from baseline)
sIgA
Salivary sIgA levels
Measured: Visit 4 (180±3 days from baseline)
α-amylase
Salivaryα-amylase levels
Measured: Visit 1 (baseline)
α-amylase
Salivary α-amylase levels
Measured: Visit 2 (5±1 days from baseline)
α-amylase
Salivary α-amylase levels
Measured: Visit 3 (90±3 days from baseline)
α-amylase
Salivary α-amylase levels
Measured: Visit 4 (180±3 days from baseline)
ASQ-3
Behaviour and cognition measurement
Measured: Visit 1 (baseline)
ASQ-3
Behaviour and cognition measurement
Measured: Visit 3 (90±3 days from baseline)
ASQ-3
Behaviour and cognition measurement
Measured: Visit 4 (180±3 days from baseline)
Growth and development
via measuring weight, height and head circumference
Measured: Visit 1 (baseline)
Growth and development
via measuring weight, height and head circumference
Measured: Visit 2 (5±1 days from baseline)
Growth and development
via measuring weight, height and head circumference
Measured: Visit 3 (90±3 days from baseline)
Growth and development
via measuring weight, height and head circumference
Measured: Visit 4 (180±3 days from baseline)
Adverse events
Record adverse events
Measured: Visit 1 (baseline)
Adverse events
Record adverse events
Measured: Visit 2 (5±1 days from baseline)
Adverse events
Record adverse events
Measured: Visit 3 (90±3 days from baseline)
Adverse events
Record adverse events
Measured: Visit 4 (180±3 days from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- a2 Milk Company Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Edanz Inc, Cyanth (Wuxi) Health Technology Co. Ltd., Shenzhen Maternity & Child Healthcare Hospital, Acurit Medical Communications Pty Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882043
- Sponsor's protocol ID
- A2MC-G240872955
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided