Investigate Effects of a2 Milk on Breastmilk Composition and Subsequent Infant Gut Health, Crying and Sleep Patterns in Healthy, Full-term Infants

Digestive System Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05829720
• Other study ID #: 22-SM-12-A2-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 17, 2023
• Est. completion date: June 10, 2023

Study information

• Verified date: April 2023
• Source: a2 Milk Company Ltd.
• Contact: Charlie Zhang, MD
• Phone: 13901981272
• Email: charlie.zhang[@]sprimmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 10, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crying
• Digestive System Disease
• Digestive System Diseases
• Gastrointestinal Diseases
• Sleepiness

Intervention

Dietary Supplement:
• a2 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.
• Conventional 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.

Locations

Country	Name	City	State
China	Jinhua Hospital of TCM,	Jinhua	Zhejiang
China	Qiu Bin Community Hospital	Jinhua	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
a2 Milk Company Ltd.

Country where clinical trial is conducted

China, 

References & Publications (10)

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. — View 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. — View 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. — View 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. Erratum In: Nutr J. 2016;15(1):45. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Erratum In: J Pediatr Gastroenterol Nutr. 2016 Mar;62(3):516. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score	Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score, range 10 to 60	Baseline (T0)
Primary	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	Infant Crying Frequency	The Frequency of Infant Crying Daily	baseline day, to day 14
Secondary	Number of Hours of Infants Sleeping	Number of Hours of Infants Sleeping Daily	baseline day, to day 14