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Not yet recruitingNCT07882043Updated Oct 20, 2026

Milk Free From A1-Type β-Casein With Human Milk Oligosaccharides on Gut Health, Immunity, Cognitive Development, and Temperament in Toddlers

An interventional study of a2 toddler milk with HMOs and Conventional toddler milk with HMOs in Healthy Volunteers, sponsored by a2 Milk Company Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 24 Months to 30 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by a2 Milk Company Ltd. · Not applicable, Interventional, and Supportive care

Updated Oct 20, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
24 Months to 30 Months
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

a2 Milk Company Ltd. is the lead sponsor of 12 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
24 Months to 30 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • (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

Exclusion criteria

Exclusion Criteria:

  • 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, 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
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    a2 toddler milk with HMOs

    containing A2 type β-casein only (A1PF)

    Other: a2 toddler milk with HMOs

  • Placebo comparator
    Conventional toddler milk with HMOs

    containing both A1 and A2 type β-caseins (CON)

    Other: Conventional toddler milk with HMOs

Interventions

  • Othera2 toddler milk with HMOs

    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).

  • OtherConventional toddler milk with HMOs

    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).

06

What researchers measure

Primary outcomes

  1. GI symptoms

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

    Time frame: Visit 1 (baseline)

  2. GI symptoms

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

    Time frame: Visit 2 (5±1 days from baseline)

  3. GI symptoms

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

    Time frame: Visit 3 (90±3 days from baseline)

  4. GI symptoms

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

    Time frame: Visit 4 (180±3 days from baseline)

  5. IgG

    Blood IgG levels

    Time frame: Visit 1 (baseline)

  6. IgG

    Blood IgG levels

    Time frame: Visit 4 (180±3 days from baseline)

Secondary outcomes

  1. hsCRP

    Blood hsCRP levels

    Time frame: Visit 1 (baseline)

  2. hsCRP

    Blood hsCRP levels

    Time frame: Visit 4 (180±3 days from baseline)

  3. IL-4

    Blood IL-4 levels

    Time frame: Visit 1 (baseline)

  4. IL-4

    Blood IL-4 levels

    Time frame: Visit 4 (180±3 days from baseline)

  5. IFN-γ

    Blood IFN-γ levels

    Time frame: Visit 1 (baseline)

  6. IFN-γ

    Blood IFN-γ levels

    Time frame: Visit 4 (180±3 days from baseline)

  7. SCFA

    Faecal SCFA levels

    Time frame: Visit 1 (baseline)

  8. SCFA

    Faecal SCFA levels

    Time frame: Visit 2 (5±1 days from baseline)

  9. SCFA

    Faecal SCFA levels

    Time frame: Visit 3 (90±3 days from baseline)

  10. SCFA

    Faecal SCFA levels

    Time frame: Visit 4 (180±3 days from baseline)

  11. Faecal microflora

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

    Time frame: Visit 1 (baseline)

  12. Faecal microflora

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

    Time frame: Visit 4 (180±3 days from baseline)

  13. sIgA

    Salivary sIgA levels

    Time frame: Visit 1 (baseline)

  14. sIgA

    Salivary sIgA levels

    Time frame: Visit 2 (5±1 days from baseline)

  15. sIgA

    Salivary sIgA levels

    Time frame: Visit 3 (90±3 days from baseline)

  16. sIgA

    Salivary sIgA levels

    Time frame: Visit 4 (180±3 days from baseline)

  17. α-amylase

    Salivaryα-amylase levels

    Time frame: Visit 1 (baseline)

  18. α-amylase

    Salivary α-amylase levels

    Time frame: Visit 2 (5±1 days from baseline)

  19. α-amylase

    Salivary α-amylase levels

    Time frame: Visit 3 (90±3 days from baseline)

  20. α-amylase

    Salivary α-amylase levels

    Time frame: Visit 4 (180±3 days from baseline)

  21. ASQ-3

    Behaviour and cognition measurement

    Time frame: Visit 1 (baseline)

  22. ASQ-3

    Behaviour and cognition measurement

    Time frame: Visit 3 (90±3 days from baseline)

  23. ASQ-3

    Behaviour and cognition measurement

    Time frame: Visit 4 (180±3 days from baseline)

  24. Growth and development

    via measuring weight, height and head circumference

    Time frame: Visit 1 (baseline)

  25. Growth and development

    via measuring weight, height and head circumference

    Time frame: Visit 2 (5±1 days from baseline)

  26. Growth and development

    via measuring weight, height and head circumference

    Time frame: Visit 3 (90±3 days from baseline)

  27. Growth and development

    via measuring weight, height and head circumference

    Time frame: Visit 4 (180±3 days from baseline)

  28. Adverse events

    Record adverse events

    Time frame: Visit 1 (baseline)

  29. Adverse events

    Record adverse events

    Time frame: Visit 2 (5±1 days from baseline)

  30. Adverse events

    Record adverse events

    Time frame: Visit 3 (90±3 days from baseline)

  31. Adverse events

    Record adverse events

    Time frame: Visit 4 (180±3 days from baseline)

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for Dec 2027, 13 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 12, 2026
First posted
Oct 20, 2026
StartEst.
Nov 2026
Primary completionEst.
Dec 2027
CompletionEst.
Dec 2027
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07882043
Lead sponsor
a2 Milk Company Ltd.
Collaborators
Edanz Inc, Cyanth (Wuxi) Health Technology Co. Ltd., Shenzhen Maternity & Child Healthcare Hospital, Acurit Medical Communications Pty Ltd
Responsible party
Sponsor
First posted
Oct 20, 2026
Start date
Nov 2026 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Oct 20, 2026

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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a2 Milk Company Ltd.

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