Comparative Effects of A2 Platinum Stage 1 Infant Formula on Infant Digestion and Comfort

NCT04733937 | Completed

• 1 other identifier: A2MC-G190549140
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 5

Brief Summary

This trial is a single-blind, randomized, controlled, parallel-designed trial to compare the effects of a2 Platinum® stage 1 infant formula versus conventional, A1 and A2 β-casein-containing stage 1 infant formula versus breastfeeding on crying, tolerance, gut health, and immune function.

Conditions

Healthy Infants

Outcome Measures

Primary Outcomes (3)

• Changes of crying frequency at each follow up visit compared to baseline

  Record frequency of crying (times/d)

  Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 days after baseline); Visit 4 (28 days after baseline)

• Changes of crying duration at each follow up visit compared to baseline

  Record duration of crying (min)

  Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 day after baseline); Visit 4 (28 days after baseline)

• Changes in fecal MPO levels at each follow up visit compared to baseline

  Record fecal MPO (in Unit) as markers of inflammation

  Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 day after baseline); Visit 4 (28 days after baseline)

Secondary Outcomes (6)

• Changes in salivary cortisol levels at each follow up visit compared to baseline

  Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 day after baseline); Visit 4 (28 days after baseline)

• Changes in body length

  Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 days after baseline); Visit 4 (28 days after baseline)

• Changes in body weight

  Visit 1 (screening/randomization); Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 day after baseline); Visit 4 (28 days after baseline)

• Changes in head circumference

  Visit 1 (screening/randomization); Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 day after baseline); Visit 4 (28 days after baseline)

• Number of adverse events at each follow up visit compared to baseline

  Visit 1 (screening/randomization); Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 day after baseline); Visit 4 (28 days after baseline)

Study Arms (3)

a2 Group

ACTIVE COMPARATOR

The infant group consuming a2 Platinum® stage 1 infant formula

Other: a2 Platinum® stage 1 infant formula

Control Group

ACTIVE COMPARATOR

The infant group consuming conventional, A1 and A2 β-casein containing stage 1 infant formula

Other: Conventional, A1 and A2 β-casein containing stage 1 infant formula

breast feeding

NO INTERVENTION

Interventions

a2 Platinum® stage 1 infant formula OTHER

Upon randomization (if not included in the breastfed group), each participant will be provided with up to 105 days' supply of the standardized formula and up to 28 days' supply of the allocated formula. Participants and study investigators will conduct the trial via a pre-determined randomization schedule.

a2 Group

Conventional, A1 and A2 β-casein containing stage 1 infant formula OTHER

Upon randomization (if not included in the breastfed group), each participant will be provided with up to 105 days' supply of the standardized formula and up to 28 days' supply of the allocated formula. Participants and study investigators will conduct the trial via a pre-determined randomization schedule.

Control Group

Eligibility Criteria

• Age: 0 Days - 76 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• days of age after birth, inclusive (day of birth is considered day 0)
• Singleton birth
• Gestational age of 37-42 weeks (36 weeks and six days is considered 36 weeks gestational age)
• Birth weight of 2,500 g to 4,500 g
• Signed informed consent obtained for infant's participation in the survey
• Parent or guardian of infant agrees not to enrol infant in another interventional clinical survey while participating in this survey
• Parent or guardian agrees to formula-feed the baby as per the randomization schedule
• For the formula-fed groups, participants in addition to the above-listed criteria, must also meet the following criterion:
• \- Parent or guardian agrees that the baby will be fed with standardized formula upon enrolment and switched to randomized formula at baseline (90-105 days of age)
• For the breastfed group, participants in addition to the above-listed criteria, must also meet the following criterion:
• \- Parent or guardian agrees that the baby will be breast-fed

You may not qualify if:

• Infant with inborn malformation and with hereditary and/or chronic and/or inborn diseases that could interfere with the survey (e.g. being unable to breast-feed or formula-fed)
• Diseases jeopardizing intrauterine growth
• Known or increased risk of IgE-mediated cow's milk protein allergy
• (i.e. one of the biological parents and/or siblings diagnosed with similar allergy,
• asthma, hay fever, etc.)
• Infant with an acute infection or gastroenteritis at time of randomization
• Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake at time of randomization
• Participation in another clinical trial
• Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements (including to fill in the diaries and to wait with introducing weaning foods until 4 months of age, and capability and willingness to do stool sample collection, handling, processing, and storage as instructed)
• Infant is immunocompromised (according to a doctor's diagnosis of immunodeficiencies such as combined immunodeficiencies, DiGeorge Syndrome, Wiskott-Aldrich syndrome, severe congenital neutropenia and secondary immunodeficiencies linked to HIV infection, Down Syndrome or others) and children with known head/brain disease/injury such as microcephaly, macrocephaly or others
• Exit Criteria:
• Ineligibility (either arising during the trial or retrospectively having been overlooked at screening)
• Significant protocol deviation
• Significant non-compliance with product regimen or trial requirements
• An adverse event (including one occurring before the start of the trial period) which requires discontinuation of the trial product or results in inability to continue to comply with trial procedures

Sponsors & Collaborators

• a2 Milk Company Ltd.: lead
• Shanghai First Maternity and Infant Hospital: collaborator
• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Edanz Group Japan Ltd: collaborator
• Women & Children's Health Care Hospital of Linyi, China: collaborator
• Beijing Esmile Technology Co. Ltd.: collaborator
• Nanjing Maternity and Child Health Care Hospital: collaborator
• First Teaching Hospital of Tianjin University of Traditional Chinese Medicine: collaborator
• Second Hospital of Jilin University: collaborator

Study Sites (5)

Nanjing Maternity and Child Health Care Hospital

Nanjing, Jiangsu, 210004, China

Location

Second Hospital of Jilin University

Changchun, Jilin, 130041, China

Location

Women & Children's Health Care Hospital of Linyi, China

Linyi, Shandong, 276000, China

Location

Shanghai First Maternity and Infant Hospital

Shanghai, Shanghai Municipality, 200121, China

Location

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, 300192, China

Location

MeSH Terms

Interventions

Congresses as Topic

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• Jiangqin Liu, MD

  Shanghai First Maternity and Infant Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: February 2, 2021
• Study Start: July 7, 2021
• Primary Completion: April 16, 2022
• Study Completion: April 16, 2022
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)