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Completed

NCT Number: NCT05829720

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

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.

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Key information

Conditions

Digestive System Disease Behavior Communication Crying Digestive System Diseases Nonverbal Communication Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleepiness

Age range

25 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jinhua Wenrong Hospital, Jinhua, Zhejiang, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  2. 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

  3. Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score

    Time frame: Baseline (T0)

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

  4. 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

Secondary outcomes

  1. Infant Crying Frequency

    Time frame: baseline day, to day 14

    The Frequency of Infant Crying Daily

  2. Number of Hours of Infants Sleeping

    Time frame: baseline day, to day 14

    Number of Hours of Infants Sleeping Daily

Sponsors and collaborators

Lead sponsor

a2 Milk Company Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 26, 2023
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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