Investigate Effects of A2 Milk on Breastmilk Composition and Subsequent Infant Gut Health, Crying… (NCT05829720) | Clinical Trial Compass
CompletedNot Applicable
Investigate Effects of A2 Milk on Breastmilk Composition and Subsequent Infant Gut Health, Crying and Sleep Patterns in Healthy, Full-term Infants
China100 participantsStarted 2023-06-13
Plain-language 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.
Who can participate
Age range
25 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Breast milk excretion of Human Milk oligosaccharide content (HMO) content
Timeframe: Baseline (T0)
2
Breast milk excretion of Human Milk oligosaccharide content (HMO) content
Timeframe: After 14 days of supplementation (T14)
3
Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score
Timeframe: Baseline (T0)
4
Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score