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CompletedNCT05829720Updated Nov 4, 2024

Investigate Effects of A2 Milk on Breastmilk Composition and Subsequent Infant Gut Health, Crying and Sleep Patterns in Healthy, Full-term Infants

An interventional study of a2 Full Cream Milk and Conventional Milk (Weidendorf) in Digestive System Disease, Sleepiness and Crying, sponsored by a2 Milk Company Ltd.. Completed at 2 sites in China. Open to female participants aged 25 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-04.

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

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
25 Years to 45 Years
Sex
Female
01

Study summary

The goal of this interventional study is to investigate effects of a2 Full Cream Milk on Breastmilk composition and subsequent Infant gut health, crying frequency and sleep patterns in Healthy Full-term Infants.

50 mothers and thier infants will be enrolled into 2 study sites, mother and her child as one subject will be randomized to 2 groups for assigned interventions, a2 Full Cream Milk and conventional Milk (Weidendorf). The study will continue for 14 days, and 3 site visits will be made duing the study period. All data specified in the protocol will be captured and recorded into CTMS for analysis.

Researchers will compare the two groups of participants to see if a2 Full Cream Milk has significantly better breastmilk composition and improve infant's gut health, crying frequency and sleep patterns.

02

Conditions studied

  • Digestive System Disease
  • Sleepiness
  • Crying

Keywords

  • A2 Full Cream Milk
  • Breastmilk Composition
  • Gut Health
03

In context

Digestive System Diseases

406 studies on the registry are indexed under Digestive System Diseases; 79 are open to participants now.

This study's enrollment of 100 is above the median of 85 across 288 interventional studies indexed under Digestive System Diseases.

Browse Digestive System Diseases studies →

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.

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Who can participate

Ages eligible
25 Years to 45 Years
Sexes eligible
Female
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

  • Mothers who are 25 to 45 years old;
  • Mothers who are exclusively breastfeeding with healthy and full-term infants;
  • Infants of these mothers who have been exclusively breastfed since birth, and their parent(s) decides to continue exclusively breastfeeding until at least 120 days of age, birth weight between 2500g and 4500g;
  • Willing to sign ICF before the study launched.

Exclusion criteria

Exclusion Criteria:

  • Mothers with infection or have recently taken the flu / covid vaccine in the last 4 weeks;
  • Infant with inborn malformation and with hereditary and/or chronic and/or inborn diseases that could interfere with the survey;
  • Evidence of feeding difficulties or intolerance/allergy to cow's milk (mixed-fed group only);
  • Conditions requiring infant feedings other than those specified in the protocol;
  • Significant systemic disorders (cardiac, respiratory, endocrinological, hematologic, gastrointestinal, or other); or parental refusal to participate;
  • Infants with an acute infection or gastroenteritis at time of enrollment;
  • Participation in another clinical trial;
  • Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    a2 Full Cream Milk

    a2 Full Cream Milk, 200ml/bag, per 100ml serving Nutrient Composition Energy: 250 kcal Protein:3.2g Fat:3.3g Carbohydrate:4.3g Sodium:40mg Calcium:104mg

    Dietary Supplement: a2 Full Cream Milk

  • Active comparator
    Conventional Milk (Weidendorf)

    Conventional Milk (Weidendorf), 200ml/bag,per 100ml serving Nutrient Composition Energy: 267 kcal Protein:3.3g Fat:3.5g Carbohydrate:4.8g Sodium:50mg Calcium:120mg

    Dietary Supplement: Conventional Milk (Weidendorf)

Interventions

  • Dietary supplementa2 Full Cream Milk

    Mothers in this arm will drink a2 Full Cream Milk twice a day, 200ml each time, for 14 consecutive days. Infants in this arm will be fed with mather's breastmilk exclusively.

  • Dietary supplementConventional Milk (Weidendorf)

    Mothers in this arm will drink Conventional Milk (Weidendorf) twice a day, 200ml each time, for 14 consecutive days. Infants in this arm will be fed with mather's breastmilk exclusively.

06

What researchers measure

Primary outcomes

  1. Breast milk excretion of Human Milk oligosaccharide content (HMO) content

    Qualitative analysis of Breast milk excretion of Human Milk oligosaccharide content (HMO) content on baseline day

    Time frame: Baseline (T0)

  2. Breast milk excretion of Human Milk oligosaccharide content (HMO) content

    Qualitative analysis of Breast milk excretion of Human Milk oligosaccharide content (HMO) content on day 14

    Time frame: After 14 days of supplementation (T14)

  3. Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score

    Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score, range 10 to 60

    Time frame: Baseline (T0)

  4. Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score

    Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score, range 10 to 60

    Time frame: After 14 days of supplementation (T14)

Secondary outcomes

  1. Infant Crying Frequency

    The Frequency of Infant Crying Daily

    Time frame: baseline day, to day 14

  2. Number of Hours of Infants Sleeping

    Number of Hours of Infants Sleeping Daily

    Time frame: baseline day, to day 14

07

Study locations

2 sites
  • Jinhua Wenrong Hospital
    Jinhua, Zhejiang, China
  • Qiu Bin Community Hospital
    Jinhua, Zhejiang, China
08

References and documents

Publications

  • Jianqin S, Leiming X, Lu X, Yelland GW, Ni J, Clarke AJ. Effects of milk containing only A2 beta casein versus milk containing both A1 and A2 beta casein proteins on gastrointestinal physiology, symptoms of discomfort, and cognitive behavior of people with self-reported intolerance to traditional cows' milk. Nutr J. 2016 Apr 2;15:35. doi: 10.1186/s12937-016-0147-z. Erratum In: Nutr J. 2016 Apr 29;15(1):45. doi: 10.1186/s12937-016-0164-y. PubMed 27039383 ↗
  • He M, Sun J, Jiang ZQ, Yang YX. Effects of cow's milk beta-casein variants on symptoms of milk intolerance in Chinese adults: a multicentre, randomised controlled study. Nutr J. 2017 Oct 25;16(1):72. doi: 10.1186/s12937-017-0275-0. PubMed 29070042 ↗
  • Sheng X, Li Z, Ni J, Yelland G. Effects of Conventional Milk Versus Milk Containing Only A2 beta-Casein on Digestion in Chinese Children: A Randomized Study. J Pediatr Gastroenterol Nutr. 2019 Sep;69(3):375-382. doi: 10.1097/MPG.0000000000002437. PubMed 31305326 ↗
  • Sheng XY, Buthmanaban V, van Lieshout GAA, Parikh P. Reduced Occurrence of Gastrointestinal Symptoms in Chinese Infants Fed Minimally Processed Commercially Available Formula: A Cross-Sectional Observational Study. J Nutr Metab. 2020 Mar 25;2020:1807397. doi: 10.1155/2020/1807397. eCollection 2020. PubMed 32300486 ↗
  • Iacono G, Merolla R, D'Amico D, Bonci E, Cavataio F, Di Prima L, Scalici C, Indinnimeo L, Averna MR, Carroccio A; Paediatric Study Group on Gastrointestinal Symptoms in Infancy. Gastrointestinal symptoms in infancy: a population-based prospective study. Dig Liver Dis. 2005 Jun;37(6):432-8. doi: 10.1016/j.dld.2005.01.009. Epub 2005 Mar 2. PubMed 15893282 ↗
  • van de Heijning BJ, Berton A, Bouritius H, Goulet O. GI symptoms in infants are a potential target for fermented infant milk formulae: a review. Nutrients. 2014 Sep 25;6(9):3942-67. doi: 10.3390/nu6093942. PubMed 25255831 ↗
  • Ferreira-Maia AP, Matijasevich A, Wang YP. Epidemiology of functional gastrointestinal disorders in infants and toddlers: A systematic review. World J Gastroenterol. 2016 Jul 28;22(28):6547-58. doi: 10.3748/wjg.v22.i28.6547. PubMed 27605889 ↗
  • Vandenplas Y, Abkari A, Bellaiche M, Benninga M, Chouraqui JP, Cokura F, Harb T, Hegar B, Lifschitz C, Ludwig T, Miqdady M, de Morais MB, Osatakul S, Salvatore S, Shamir R, Staiano A, Szajewska H, Thapar N. Prevalence and Health Outcomes of Functional Gastrointestinal Symptoms in Infants From Birth to 12 Months of Age. J Pediatr Gastroenterol Nutr. 2015 Nov;61(5):531-7. doi: 10.1097/MPG.0000000000000949. PubMed 26308317 ↗
  • Shamir R, St James-Roberts I, Di Lorenzo C, Burns AJ, Thapar N, Indrio F, Riezzo G, Raimondi F, Di Mauro A, Francavilla R, Leuchter RH, Darque A, Huppi PS, Heine RG, Bellaiche M, Levy M, Jung C, Alvarez M, Hovish K. Infant crying, colic, and gastrointestinal discomfort in early childhood: a review of the evidence and most plausible mechanisms. J Pediatr Gastroenterol Nutr. 2013 Dec;57 Suppl 1:S1-45. doi: 10.1097/MPG.0b013e3182a154ff. No abstract available. PubMed 24356023 ↗
  • Ul Haq MR, Kapila R, Sharma R, Saliganti V, Kapila S. Comparative evaluation of cow beta-casein variants (A1/A2) consumption on Th2-mediated inflammatory response in mouse gut. Eur J Nutr. 2014 Jun;53(4):1039-49. doi: 10.1007/s00394-013-0606-7. Epub 2013 Oct 29. PubMed 24166511 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05829720
Lead sponsor
a2 Milk Company Ltd.
Responsible party
Sponsor
First posted
Apr 26, 2023
Start date
Jun 13, 2023
Primary completion
Aug 17, 2023
Completion
Aug 17, 2023
Last update
Nov 4, 2024

Study contacts

Zhixu Wang, MD
principal investigator · School of Public Health, Nanjing Medical University
Fan Yang, PhD
principal investigator · West China Second Hospital, Sichuan University
Yi Sun, MD
principal investigator · Shanghai Tongren Hospital

Oversight

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

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