Digestive System DiseaseNCT05829720

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

A study testing a2 Full Cream Milk and Conventional Milk (Weidendorf) in people with Digestive System Disease and Sleepiness, run by a2 Milk Company Ltd. at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 25 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Digestive System Disease, Sleepiness, Crying
What is being tested?: a2 Full Cream Milk and Conventional Milk (Weidendorf)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 2 sitesChina
Study dates: 13 Jun 2023to 17 Aug 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

2 sites in 1 country.

China2 sites

Jinhua Wenrong Hospital
Jinhua, Zhejiang
Qiu Bin Community Hospital
Jinhua, Zhejiang

Other trials in China

About this study

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

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
Being tested: a2 Full Cream Milk, Conventional Milk (Weidendorf)
Keywords: A2 Full Cream Milk, Breastmilk Composition, Gut Health
Medical subject headings: Digestive System Diseases, Sleepiness, Crying

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

a2 Full Cream MilkDietary 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.
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.

Study groups in NCT05829720
Study group	Role	What they receive
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 Receives: 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 Receives: Dietary Supplement: Conventional Milk (Weidendorf)

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: After 14 days of supplementation (T14)
Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score
Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score, range 10 to 60
Measured: Baseline (T0)
Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score
Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score, range 10 to 60
Measured: After 14 days of supplementation (T14)

Secondary outcomes (2)

Infant Crying Frequency
The Frequency of Infant Crying Daily
Measured: baseline day, to day 14
Number of Hours of Infants Sleeping
Number of Hours of Infants Sleeping Daily
Measured: baseline day, to day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jun 202317 Aug 2023

First posted26 Apr 2023
Study start13 Jun 2023
Primary completion17 Aug 2023
Study completion17 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Digestive System DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05829720
Sponsor's protocol ID: 22-SM-12-A2-001
Status last verified: Oct 2024
First submitted: 3 Apr 2023
Last updated: 4 Nov 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05829720
Acronym / sponsor ID: 22-SM-12-A2-001
Conditions: Digestive System Disease, Sleepiness, Crying
Keywords: A2 Full Cream Milk, Breastmilk Composition, Gut Health
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: a2 Milk Company Ltd.Industry (pharma, biotech, devices)
Study start: 13 Jun 2023 (actual)
Primary completion: 17 Aug 2023 (actual)
Study completion: 17 Aug 2023 (actual)
First posted: 26 Apr 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
a2 Full Cream Milk	Active comparator	Dietary Supplement: a2 Full Cream Milka2 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
Conventional Milk (Weidendorf)	Active comparator	Dietary Supplement: 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

Who may qualify

Ages: 25 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (8 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
a2 Full Cream MilkMothers 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 supplement	a2 Full Cream Milk
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.	Dietary supplement	Conventional Milk (Weidendorf)

Primary outcome

Breast milk excretion of Human Milk oligosaccharide content (HMO) content
Time frame: Baseline (T0)
Qualitative analysis of Breast milk excretion of Human Milk oligosaccharide content (HMO) content on baseline day
Breast milk excretion of Human Milk oligosaccharide content (HMO) content
Time frame: After 14 days of supplementation (T14)
Qualitative analysis of Breast milk excretion of Human Milk oligosaccharide content (HMO) content on day 14
Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score
Time frame: Baseline (T0)
Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score, range 10 to 60
Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score
Time frame: After 14 days of supplementation (T14)
Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score, range 10 to 60

2 secondary outcomes

Infant Crying Frequency
Time frame: baseline day, to day 14
Number of Hours of Infants Sleeping
Time frame: baseline day, to day 14

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
Background: PubMed 27039383Jianqin 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.
Background: PubMed 29070042He 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.
Background: PubMed 31305326Sheng 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.
Background: PubMed 32300486Sheng 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.
Background: PubMed 15893282Iacono 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.
Background: PubMed 25255831van 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.
Background: PubMed 27605889Ferreira-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.
Background: PubMed 26308317Vandenplas 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.
Background: PubMed 24356023Shamir 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.
Background: PubMed 24166511Ul 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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 Tong Ren Hospital

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing a2 Full Cream Milk and Conventional Milk (Weidendorf) in people with Digestive System Disease and Sleepiness, run by a2 Milk Company Ltd. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Breast milk excretion of Human Milk oligosaccharide content (HMO) content (time frame: Baseline (T0)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05829720, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.