Clinical trial NCT05829720: Investigate Effects of A2 Milk on Breastmilk Composition and Subsequent Infant Gut Health, Crying and Sleep Patterns in Healthy, Full-term Infants
Official title: A Double-blind, Parallel Designed, Randomized Controlled Trial to Investigate Effects of Conventional Vs A2 Milk on Breastmilk Composition and Subsequent Infant Gut Health, Crying and Sleep Patterns in Healthy, Full-term Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Digestive System Disease
Sleepiness
Crying
Keywords: A2 Full Cream Milk
Breastmilk Composition
Gut Health
Lead sponsor: a2 Milk Company Ltd.
Sponsor class: INDUSTRY
First posted: 2023-04-26
Enrollment: 100
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Breast milk excretion of Human Milk oligosaccharide content (HMO) content
timeFrame: Baseline (T0)
measure: Breast milk excretion of Human Milk oligosaccharide content (HMO) content
timeFrame: After 14 days of supplementation (T14)
measure: Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score
timeFrame: Baseline (T0)
measure: Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score
timeFrame: After 14 days of supplementation (T14)
Secondary outcomes:
measure: Infant Crying Frequency
timeFrame: baseline day, to day 14
measure: Number of Hours of Infants Sleeping
timeFrame: baseline day, to day 14
Other outcomes:
Locations:
city: Jinhua
country: China
facility: Jinhua Wenrong Hospital
state: Zhejiang
city: Jinhua
country: China
facility: Qiu Bin Community Hospital
state: Zhejiang
Study officials:
affiliation: School of Public Health, Nanjing Medical University
name: Zhixu Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: West China Second Hospital, Sichuan University
name: Fan Yang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Tongren Hospital
name: Yi Sun, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.