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

NCT05829720 | Completed

• 1 other identifier: 22-SM-12-A2-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Digestive System Disease; Sleepiness; Crying

Keywords

A2 Full Cream Milk; Breastmilk Composition; Gut Health

Outcome Measures

Primary Outcomes (4)

• 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

  Baseline (T0)

• 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

  After 14 days of supplementation (T14)

• Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score

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

  Baseline (T0)

• Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score

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

  After 14 days of supplementation (T14)

Secondary Outcomes (2)

• Infant Crying Frequency

  baseline day, to day 14

• Number of Hours of Infants Sleeping

  baseline day, to day 14

Study Arms (2)

a2 Full Cream Milk

ACTIVE COMPARATOR

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

Conventional Milk (Weidendorf)

ACTIVE COMPARATOR

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

a2 Full Cream Milk DIETARY_SUPPLEMENT

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.

a2 Full Cream Milk

Conventional Milk (Weidendorf) DIETARY_SUPPLEMENT

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.

Conventional Milk (Weidendorf)

Eligibility Criteria

• Age: 25 Years - 45 Years
• Gender Eligibility Details: Mothers who are exclusively breastfeeding with healthy and full-term infants, infants as participants can be male or female.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• a2 Milk Company Ltd.: lead

Study Sites (2)

Jinhua Wenrong Hospital

Jinhua, Zhejiang, China

Location

Qiu Bin Community Hospital

Jinhua, Zhejiang, China

Location

Related Publications (10)

• 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.

  PMID: 27039383 BACKGROUND

• 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.

  PMID: 29070042 BACKGROUND

• 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.

  PMID: 31305326 BACKGROUND

• 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.

  PMID: 32300486 BACKGROUND

• 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.

  PMID: 15893282 BACKGROUND

• 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.

  PMID: 25255831 BACKGROUND

• 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.

  PMID: 27605889 BACKGROUND

• 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.

  PMID: 26308317 BACKGROUND

• 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.

  PMID: 24356023 BACKGROUND

• 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.

  PMID: 24166511 BACKGROUND

MeSH Terms

Conditions

Digestive System Diseases; Sleepiness; Crying

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nonverbal Communication; Communication; Behavior

Study Officials

• Zhixu Wang, MD

  School of Public Health, Nanjing Medical University

  PRINCIPAL INVESTIGATOR

• Fan Yang, PhD

  West China Second Hospital, Sichuan University

  PRINCIPAL INVESTIGATOR

• Yi Sun, MD

  Shanghai Tongren Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 26, 2023
• Study Start: June 13, 2023
• Primary Completion: August 17, 2023
• Study Completion: August 17, 2023
• Last Updated: November 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)