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

NCT07882043 | Not Yet Recruiting

• 1 other identifier: A2MC-G240872955
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (6)

• GI symptoms

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

  Visit 1 (baseline)

• GI symptoms

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

  Visit 2 (5±1 days from baseline)

• GI symptoms

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

  Visit 3 (90±3 days from baseline)

• GI symptoms

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

  Visit 4 (180±3 days from baseline)

• IgG

  Blood IgG levels

  Visit 1 (baseline)

• IgG

  Blood IgG levels

  Visit 4 (180±3 days from baseline)

Secondary Outcomes (31)

• hsCRP

  Visit 1 (baseline)

• hsCRP

  Visit 4 (180±3 days from baseline)

• IL-4

  Visit 1 (baseline)

• IL-4

  Visit 4 (180±3 days from baseline)

• IFN-γ

  Visit 1 (baseline)

Study Arms (2)

a2 toddler milk with HMOs

ACTIVE COMPARATOR

containing A2 type β-casein only (A1PF)

Other: a2 toddler milk with HMOs

Conventional toddler milk with HMOs

PLACEBO COMPARATOR

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

Other: Conventional toddler milk with HMOs

Interventions

a2 toddler milk with HMOs OTHER

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).

a2 toddler milk with HMOs

Conventional toddler milk with HMOs OTHER

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).

Conventional toddler milk with HMOs

Eligibility Criteria

• Age: 24 Months - 30 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• (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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• a2 Milk Company Ltd.: lead
• Edanz Inc: collaborator
• Cyanth (Wuxi) Health Technology Co. Ltd.: collaborator
• Shenzhen Maternity & Child Healthcare Hospital: collaborator
• Acurit Medical Communications Pty Ltd: collaborator

Study Sites (1)

Shenzhen Maternity & Child Healthcare Hospital

Shenzhen, Guagndong, 518028, China

Location

MeSH Terms

Interventions

Health Maintenance Organizations

Intervention Hierarchy (Ancestors)

Managed Care Programs; Insurance, Health; Insurance; Financing, Organized; Economics; Health Care Economics and Organizations; Prepaid Health Plans; Group Practice; Professional Practice; Organization and Administration; Health Services Administration; Delivery of Health Care; Patient Care Management

Central Study Contacts

Yuting Dai

CONTACT

+86 0755 8286 9849; 1101739264@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2026
• First Posted: October 20, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 20, 2026

Record last verified: 2026-10

Locations

CN (1)