Back to resultsInvestigate Effects of a2 Milk on Breastmilk Composition and Subsequent Infant Gut Health, Crying and Sleep Patterns in Healthy, Full-term Infants
Primary Purpose
Digestive System Disease, Sleepiness, Crying
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
a2 Full Cream Milk
Conventional Milk (Weidendorf)
Sponsored by
About this trial
This is an interventional supportive care trial for Digestive System Disease focused on measuring A2 Full Cream Milk, Breastmilk Composition, Gut Health
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.
Sites / Locations
- Jinhua Hospital of TCM,
- Qiu Bin Community Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
a2 Full Cream Milk
Conventional Milk (Weidendorf)
Arm Description
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
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
Outcomes
Primary Outcome Measures
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
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
Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score
Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score, range 10 to 60
Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score
Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score, range 10 to 60
Secondary Outcome Measures
Infant Crying Frequency
The Frequency of Infant Crying Daily
Number of Hours of Infants Sleeping
Number of Hours of Infants Sleeping Daily
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05829720
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 17, 2023 (Anticipated)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
June 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
a2 Milk Company Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Digestive System Disease, Sleepiness, Crying
Keywords
A2 Full Cream Milk, Breastmilk Composition, Gut Health
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
a2 Full Cream Milk
Arm Type
Active Comparator
Arm Description
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
Arm Title
Conventional Milk (Weidendorf)
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
a2 Full Cream Milk
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Conventional Milk (Weidendorf)
Intervention Description
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 Outcome Measure Information:
Title
Breast milk excretion of Human Milk oligosaccharide content (HMO) content
Description
Qualitative analysis of Breast milk excretion of Human Milk oligosaccharide content (HMO) content on baseline day
Time Frame
Baseline (T0)
Title
Breast milk excretion of Human Milk oligosaccharide content (HMO) content
Description
Qualitative analysis of Breast milk excretion of Human Milk oligosaccharide content (HMO) content on day 14
Time Frame
After 14 days of supplementation (T14)
Title
Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score
Description
Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score, range 10 to 60
Time Frame
Baseline (T0)
Title
Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score
Description
Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score, range 10 to 60
Time Frame
After 14 days of supplementation (T14)
Secondary Outcome Measure Information:
Title
Infant Crying Frequency
Description
The Frequency of Infant Crying Daily
Time Frame
baseline day, to day 14
Title
Number of Hours of Infants Sleeping
Description
Number of Hours of Infants Sleeping Daily
Time Frame
baseline day, to day 14
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Mothers who are exclusively breastfeeding with healthy and full-term infants, infants as participants can be male or female.
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charlie Zhang, MD
Phone
13901981272
Email
charlie.zhang@sprimmedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhixu Wang, MD
Organizational Affiliation
School of Public Health, Nanjing Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fan Yang, PhD
Organizational Affiliation
West China Second Hospital, Sichuan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yi Sun, MD
Organizational Affiliation
Shanghai Tongren Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jinhua Hospital of TCM,
City
Jinhua
State/Province
Zhejiang
Country
China
Facility Name
Qiu Bin Community Hospital
City
Jinhua
State/Province
Zhejiang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlie Zhang, MD
Phone
+8613901981272
Email
charlie.zhang@sprimmedical.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Learn more about this trial
Investigate Effects of a2 Milk on Breastmilk Composition and Subsequent Infant Gut Health, Crying and Sleep Patterns in Healthy, Full-term Infants
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