Clinical trial NCT06256094: The Effects of a2 Infant Formula on Growth and Tolerance in Healthy Term Infants
Official title: The Effects of a2 Infant Formula on Growth and Tolerance in Healthy Term Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: a2 Milk Company Ltd.
Sponsor class: INDUSTRY
First posted: 2024-02-13
Enrollment: 280
Sex: ALL
Minimum age (years): 60
Maximum age (years): 120
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Body weight measured in gram.
timeFrame: Baseline, Day 14, Day 28, Day 56
Secondary outcomes:
measure: Body length measured in centimeter.
timeFrame: Baseline, Day 14, Day 28, Day 56
measure: Head circumference measured in centimeter.
timeFrame: Baseline, Day 14, Day 28, Day 56
measure: Body mass index calculated from body weight and length.
timeFrame: Baseline, Day 14, Day 28, Day 56
measure: 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
timeFrame: Baseline, Day 14, Day 28, Day 56
measure: 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
timeFrame: Baseline, Day 14, Day 28, Day 56
measure: 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
timeFrame: Baseline, Day 14, Day 28, Day 56
measure: 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
timeFrame: Baseline, Day 14, Day 28, Day 56
measure: 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
timeFrame: Baseline, Day 14, Day 28, Day 56
measure: Infants' gastrointestinal symptom score evaluated using the Infant Gastrointestinal Symptom Questionnaire (IGSQ)
timeFrame: Baseline, Day 14, Day 28, Day 56
measure: Number of crying periods evaluated in each 15-minutes period during a day
timeFrame: Baseline, Day 14, Day 28, Day 56
measure: Infants' Dermatitis Quality of Life Index (IDQoL) that measured participants' quality of life related to dermatitis
timeFrame: Baseline, Day 14, Day 28, Day 56
measure: Average daily formula intake amount (ml/day) during the past week measured by formula intake diary
timeFrame: Baseline, Day 14, Day 28, Day 56
measure: Percent of participants with relieved gastrointestinal symptoms by the end of the study, evaluated using the Formula Satisfaction Questionnaire
timeFrame: Day 56
measure: Percent of participants with relieved skin symptoms by the end of the study, evaluated using the Formula Satisfaction Questionnaire
timeFrame: Day 56
measure: 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
timeFrame: Day 56
measure: Percent of overall satisfaction levels with the study formula, measured in 4 levels: Satisfied, Neutral, Dissatisfied, or Not sure using the Formula Satisfaction Questionnaire
timeFrame: Day 56
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Weierkang Pediatric Outpatient Department
Study officials:
affiliation: Adjuvant Advertising (Shanghai) Co., Ltd
name: Frank Wang
role: STUDY_DIRECTOR
References: