The Effects of a2 Infant Formula on Growth and Tolerance in Healthy Term Infants

Healthy Clinical Trial

Official title:

The Effects of a2 Infant Formula on Growth and Tolerance in Healthy Term Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06256094
• Other study ID #: A2220616005
• Status: Completed
• Phase: N/A
• Start date: July 14, 2023
• Est. completion date: November 3, 2023

Study information

• Verified date: January 2024
• Source: a2 Milk Company Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, open-label, prospective study to evaluate the nutritive effects of an a2 infant formula on growth and tolerance in healthy term infants. A total of 280 healthy, term, mixed-fed infants between 60 and 120 days of age were enrolled at Shanghai. The participants were randomly assigned to one of the two study groups: the a2 infant formula group and the conventional A1/A2 infant formula group. Each group contained 140 infants. The study duration was 56 days.

Description:

Primary objective:

To compare the growth measurements of the infants fed with the a2 infant formula with those fed with conventional A1/A2 infant formula during the study period.

Secondary objectives:

To compare the two study groups in

1. Dermatitis quality of life

2. Formula tolerability and acceptability

3. All medically confirmed adverse events

The study included four visits at day 0 (baseline), day 14, day 28 and day 56. Information of efficacy outcomes were collected at each visit. Subject diary was used to record tolerance data and daily formula feeding amount during the study. The parents of the participants were also required evaluate their satisfaction with the study formula at the last visit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: November 3, 2023
• Est. primary completion date: November 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Days to 120 Days

Eligibility

Inclusion Criteria:

• Healthy and term infants (37-42 weeks gestation);

• Birth weight between 2500g and 4500g;

• 60-120 days of age after birth;

• Mixed-fed: Infants who were fed with a mixture of formula and human milk, and received daily formula consumption of more than 400ml;

• Signed informed consent obtained form the guardian(s) of the infants;

• Parent or guardian of infant agrees not to enroll infant in another interventional clinical research survey while participating in this survey.

Exclusion Criteria:

• Congenital anomaly or hereditary/chronic/congenital diseases that could interfere with the study product evaluations;

• Evidence of feeding difficulties or intolerance/allergy to cow's milk;

• 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;

• Acute infection or gastroenteritis at the time of enrollment;

• Participation in other clinical trials at the time of the study;

• Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements.

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• a2 Platinum Premium Infant Formula Stage 1
Oral intake of a2 Platinum Premium Infant Formula Stage 1 milk powder (dissolved in water)
• Frisolac Infant Formula Stage 1 (Dutch Edition)
Oral intake of Frisolac Infant Formula Step 1 (Dutch Edition) milk power (dissolved in water)

Locations

Country	Name	City	State
China	Shanghai Weierkang Pediatric Outpatient Department	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
a2 Milk Company Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight measured in gram.	Body weight measured in gram.	Baseline, Day 14, Day 28, Day 56
Secondary	Body length measured in centimeter.	Body length measured in centimeter.	Baseline, Day 14, Day 28, Day 56
Secondary	Head circumference measured in centimeter.	Head circumference measured in centimeter.	Baseline, Day 14, Day 28, Day 56
Secondary	Body mass index calculated from body weight and length.	Body mass index calculated from as weight (kg) dived by the square of body length (meter).	Baseline, Day 14, Day 28, Day 56
Secondary	Weight-for-age Z-score that describe the distance and direction of the weight of a participant away from the mean of the population of the same age	A standard score for measuring weight growth calculated according to the WHO Growth Standards. The weight-for-age Z-score is the distance and direction of the weight of a participant away from the mean body weight of the population of the same age.	Baseline, Day 14, Day 28, Day 56
Secondary	Length-for-age Z-score that describe the distance and direction of the body length of a participant away from the mean body length of the population of the same age	A standard score for measuring body length growth calculated according to the WHO Growth Standards. The length-for-age Z-score is the distance and direction of the body length of a participant away from the mean body length of the population of the same age.	Baseline, Day 14, Day 28, Day 56
Secondary	BMI-for-age Z-score that describe the distance and direction of the body mass index of a participant away from the mean body mass index of the population of the same age	A standard score for measuring body mass index (BMI) calculated according to the WHO Growth Standards. The BMI-for-age Z-score is the distance and direction of the body mass index of a participant away from the mean body mass index of the population of the same age.	Baseline, Day 14, Day 28, Day 56
Secondary	Head circumference-for-age Z-score that describe the distance and direction of the head circumference of a participant away from the mean head circumference of the population of the same age	A standard score for measuring head circumference calculated according to the WHO Growth Standards. The head circumference-for-age Z-score is the distance and direction of the head circumference of a participant away from the mean head circumference of the population of the same age.	Baseline, Day 14, Day 28, Day 56
Secondary	Weight-for-length Z-score that describe the distance and direction of the weight of a participant away from the mean weight of the population of the same body length	A standard score for measuring weight-for-length growth calculated according to the WHO Growth Standards. The weight-for-length Z-score is the distance and direction of the body weight of a participant away from the mean body weight of the population of the same body length.	Baseline, Day 14, Day 28, Day 56
Secondary	Infants' gastrointestinal symptom score evaluated using the Infant Gastrointestinal Symptom Questionnaire (IGSQ)	The IGSQ score is the sum of 5 domains scores of stooling, spitting up/vomiting, crying, fussiness and flatulence, derived by summing up the relating raw individual scores. Each raw score range from 0 to 5, with higher score indicating more severe gastrointestinal symptoms. Data was collected daily, and the average score during the past week of each visit was used for analyses.	Baseline, Day 14, Day 28, Day 56
Secondary	Number of crying periods evaluated in each 15-minutes period during a day	Number of 15-minute periods at morning, afternoon, evening and night, and the daily total number of crying periods. Data was collected daily, and the average daily number of crying periods during the past week of each visit was used for analyses.	Baseline, Day 14, Day 28, Day 56
Secondary	Infants' Dermatitis Quality of Life Index (IDQoL) that measured participants' quality of life related to dermatitis	An index to evaluate the quality of life related to dermatitis during the past week of each visit. The IDQoL index is the sum of one score for evaluating dermatitis severity (range from 0 to 4 indicating increasing severity from no symptom to very servere symptom) and 10 individual scores (each range from 0 to 3 indicating increasing frequency from none to very often) evaluating the possible problems encountered in daily life due to dermatitis, including itching and scratching, mood, time to get to sleep, sleep disturbance, disturbed playing or swimming, disturbed family activities, problems during meal times, problems from treatment, problems at dressing, and problems at bath time.	Baseline, Day 14, Day 28, Day 56
Secondary	Average daily formula intake amount (ml/day) during the past week measured by formula intake diary	Daily formula intake amount was recorded in ml. The average daily formula intake amount during the past week of each visit was used to assess formula feeding amount.	Baseline, Day 14, Day 28, Day 56
Secondary	Percent of participants with relieved gastrointestinal symptoms by the end of the study, evaluated using the Formula Satisfaction Questionnaire	Parents were required to report whether the gastrointestinal symptoms of the participant have been relieved by the end of the study. Dichotomized variable with 2 levels: Yes or No.	Day 56
Secondary	Percent of participants with relieved skin symptoms by the end of the study, evaluated using the Formula Satisfaction Questionnaire	Parents were required to report whether participant's skin symptoms such as eczema or dermatitis have been relieved by the end of the study. Dichotomized variable with 2 levels: Yes or No.	Day 56
Secondary	Percent of parents of the participants with intention of continuing to feed the child with the study formula, measured in 3 levels: Yes, No, or Not sure using the Formula Satisfaction Questionnaire	Parents were required to indicate their intention of continuing to feed the child with the study formula. Categorical variable with 3 levels: Yes, No, or Not sure.	Day 56
Secondary	Percent of overall satisfaction levels with the study formula, measured in 4 levels: Satisfied, Neutral, Dissatisfied, or Not sure using the Formula Satisfaction Questionnaire	Overall satisfaction with study formula was evaluated by the parents at the end of the study. Category variable with 4 levels: Satisfied, Neutral, Dissatisfied, or Not sure.	Day 56