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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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
Are there results?
Not yet: the study is under way

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.

Yuting Dai contact

+86 0755 8286 9849

1101739264@qq.com

China1 site

  • Shenzhen Maternity & Child Healthcare Hospital

    Shenzhen, Guagndong, 518028

    Yuting Dai, +86 0755 8286 9849, 1101739264@qq.com

    Yongmei Zeng, MD

Other trials in China

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.

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 groups in NCT07882043
Study groupRoleWhat they receive
a2 toddler milk with HMOsActive comparatorcontaining A2 type β-casein only (A1PF)
Receives: Other: a2 toddler milk with HMOs
Conventional toddler milk with HMOsPlacebo comparatorcontaining 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.

  1. GI symptoms

    Visual analogue scale (VAS) score for gastrointestinal (GI) symptoms

    Measured: Visit 1 (baseline)

  2. GI symptoms

    Visual analogue scale (VAS) score for gastrointestinal (GI) symptoms

    Measured: Visit 2 (5±1 days from baseline)

  3. GI symptoms

    Visual analogue scale (VAS) score for gastrointestinal (GI) symptoms

    Measured: Visit 3 (90±3 days from baseline)

  4. GI symptoms

    Visual analogue scale (VAS) score for gastrointestinal (GI) symptoms

    Measured: Visit 4 (180±3 days from baseline)

  5. IgG

    Blood IgG levels

    Measured: Visit 1 (baseline)

  6. IgG

    Blood IgG levels

    Measured: Visit 4 (180±3 days from baseline)

Secondary outcomes (31)

  1. hsCRP

    Blood hsCRP levels

    Measured: Visit 1 (baseline)

  2. hsCRP

    Blood hsCRP levels

    Measured: Visit 4 (180±3 days from baseline)

  3. IL-4

    Blood IL-4 levels

    Measured: Visit 1 (baseline)

  4. IL-4

    Blood IL-4 levels

    Measured: Visit 4 (180±3 days from baseline)

  5. IFN-γ

    Blood IFN-γ levels

    Measured: Visit 1 (baseline)

  6. IFN-γ

    Blood IFN-γ levels

    Measured: Visit 4 (180±3 days from baseline)

  7. SCFA

    Faecal SCFA levels

    Measured: Visit 1 (baseline)

  8. SCFA

    Faecal SCFA levels

    Measured: Visit 2 (5±1 days from baseline)

  9. SCFA

    Faecal SCFA levels

    Measured: Visit 3 (90±3 days from baseline)

  10. SCFA

    Faecal SCFA levels

    Measured: Visit 4 (180±3 days from baseline)

  11. Faecal microflora

    Faecal microflora, including species phylogenetic analysis, Alpha diversity, and Beta diversity analysis.

    Measured: Visit 1 (baseline)

  12. Faecal microflora

    Faecal microflora, including species phylogenetic analysis, Alpha diversity, and Beta diversity analysis.

    Measured: Visit 4 (180±3 days from baseline)

  13. sIgA

    Salivary sIgA levels

    Measured: Visit 1 (baseline)

  14. sIgA

    Salivary sIgA levels

    Measured: Visit 2 (5±1 days from baseline)

  15. sIgA

    Salivary sIgA levels

    Measured: Visit 3 (90±3 days from baseline)

  16. sIgA

    Salivary sIgA levels

    Measured: Visit 4 (180±3 days from baseline)

  17. α-amylase

    Salivaryα-amylase levels

    Measured: Visit 1 (baseline)

  18. α-amylase

    Salivary α-amylase levels

    Measured: Visit 2 (5±1 days from baseline)

  19. α-amylase

    Salivary α-amylase levels

    Measured: Visit 3 (90±3 days from baseline)

  20. α-amylase

    Salivary α-amylase levels

    Measured: Visit 4 (180±3 days from baseline)

  21. ASQ-3

    Behaviour and cognition measurement

    Measured: Visit 1 (baseline)

  22. ASQ-3

    Behaviour and cognition measurement

    Measured: Visit 3 (90±3 days from baseline)

  23. ASQ-3

    Behaviour and cognition measurement

    Measured: Visit 4 (180±3 days from baseline)

  24. Growth and development

    via measuring weight, height and head circumference

    Measured: Visit 1 (baseline)

  25. Growth and development

    via measuring weight, height and head circumference

    Measured: Visit 2 (5±1 days from baseline)

  26. Growth and development

    via measuring weight, height and head circumference

    Measured: Visit 3 (90±3 days from baseline)

  27. Growth and development

    via measuring weight, height and head circumference

    Measured: Visit 4 (180±3 days from baseline)

  28. Adverse events

    Record adverse events

    Measured: Visit 1 (baseline)

  29. Adverse events

    Record adverse events

    Measured: Visit 2 (5±1 days from baseline)

  30. Adverse events

    Record adverse events

    Measured: Visit 3 (90±3 days from baseline)

  31. 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.

  1. First posted20 Oct 2026
  2. Study startNov 2026 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

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 13 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: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yuting Dai (+86 0755 8286 9849, 1101739264@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

GI symptoms (time frame: Visit 1 (baseline)). The study lists 6 primary outcomes in all. 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 NCT07882043.

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 20 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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